The Central Drugs Standard Control Organization (CDSCO), Government of India, has a mandate for approval of drugs to be manufactured and imported for sale in India. The drugs approved by CDSCO can only be further licensed by State Licensing Authorities to various manufacturers in India. CDSCO often publishes the list of approved drugs/new drugs on its website but the updation of the drugs is year-wise and department-wise. Also, there are numerous lists that a manufacturer has to go through to find the status of the drug that he intends to manufacture. There is no single list available mentioning the complete list of CDSCO-approved drugs in India.
Looking at this scenario, we at FedleyHealthcare have taken this onus onto ourselves to compile and organize the list of approximately 5000 products. We are hereby publishing the complete list of new drugs in one place in an easy, searchable format. We are committed to updating this list as and when the list of new approved drugs is issued by CDSCO. This initiative has been taken after a successful and widely applauded list of banned drugs and a list of solubility of Active Pharmaceutical Ingredients has been published on our website.
Fedleyhealthcare is a one-stop destination for all pharma regulatory services. In a short span of time, we have created a niche for ourselves as regulatory consultants with expertise in a wide array of regulatory activities. Our services include, but are not limited to, new drug approval, medical device registration and licensure, FDC approval, Cosmetics Licensure, GMP Layouts preparation, Auditing, Training, etc. With a 100% success record, Fedleyhealthcare boasts of a team that not only helps you with the filing process but also performs the complete technical and administrative review of the data submitted to us. This helps to reduce the concerns raised by the regulators and helps to expedite the approval process. The transparent and supportive approach has helped us win accolades among our clients.
Sr. No. - Name of the Product - Composition - Indication - Date of Approval
151. Atorvastatin Calcium Tablet 30/60 mg (Additional Strength)
Composition: Each film-coated tablet contains Atorvastatin Calcium equivalent to Atorvastatin 30 mg / 60 mg.
Indication:
Adjunct to diet to reduce elevated total cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Type IIa & IIb).
In adults with Type II diabetes without clinically evident coronary heart disease, to reduce the risk of myocardial infarction and stroke.
To reduce the risk of stroke in adults without clinically evident coronary heart disease but having multiple risk factors.
Condition: To be sold by retail on the prescription of a Cardiologist only.
Approval Date: 27.09.2019
152. Desloratadine Tablets 10 mg (Additional Strength)
Composition: Each film-coated tablet contains Desloratadine 10 mg.
Indication: For the treatment of Chronic Idiopathic Urticaria in patients who have not responded to the standard 5 mg dose of Desloratadine.
Approval Date: 27.09.2019
153. Diclofenac Sodium Rectal Solution 25% w/v with Applicator (Additional Dosage Form)
Composition:
Each ml contains Diclofenac Sodium 25% w/v.
Each squirt (0.2 ml) delivers Diclofenac Sodium 50 mg.
Indication: For mild to moderate pain in adults.
Approval Date: 27.09.2019
154. Perampanel Tablets 2 mg / 4 mg / 6 mg / 8 mg / 10 mg / 12 mg (Additional Indication)
Composition: Each film-coated tablet contains Perampanel 2 mg, 4 mg, 6 mg, 8 mg, 10 mg or 12 mg.
Indication: For adjunctive treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older.
Condition: To be sold by retail on the prescription of a Neurologist only.
Approval Date: 27.09.2019
155. Mometasone Furoate + Azelastine Hydrochloride Nasal Spray
Composition (Per Spray):
• Mometasone Furoate BP – 50 mcg
• Azelastine Hydrochloride BP – 140 mcg
• Benzalkonium Chloride BP – 0.02% w/w (Preservative)
Indication: For the relief of symptoms of seasonal allergic rhinitis in patients 12 years of age and older.
Approval Date: 30.09.2019
156. Ribociclib Film-Coated Tablet 200 mg (Additional Indication)
Composition: Ribociclib Succinate 254.40 mg equivalent to Ribociclib 200 mg.
Indication: Indicated for treatment of women with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy or after prior endocrine therapy.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 04.10.2019
157. Cilnidipine Tablet 20 mg (Additional Strength)
Composition: Each film-coated tablet contains Cilnidipine 20 mg.
Indication: For treatment of mild to moderate hypertension.
Approval Date: 11.10.2019
158. Ebastine 10 mg + Montelukast 10 mg Tablet
Composition:
• Ebastine – 10 mg
• Montelukast – 10 mg
Indication: For treatment of allergic rhinitis in adults only.
Approval Date: 14.10.2019
159. Acalabrutinib Capsules 100 mg
Composition: Acalabrutinib 100 mg Capsules.
Indication: For the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Approval Date: 18.10.2019
160. Pregabalin PR 75 mg + Etoricoxib 60 mg Tablet
Composition:
• Pregabalin IP (Prolonged Release) – 75 mg
• Etoricoxib IP – 60 mg
Indication: For the treatment of chronic low back pain associated with a neuropathic component.
Approval Date: 18.10.2019
161. Evogliptin 5 mg + Metformin SR 1000 mg Tablet
Composition:
• Evogliptin Tartrate 6.869 mg equivalent to Evogliptin 5 mg
• Metformin Hydrochloride IP (Sustained Release) – 1000 mg
Indication: Nebulization, as an adjunct to diet and exercise, to improve glycemic control in adults with Type 2 Diabetes Mellitus who are appropriate for co-administration of Evogliptin and Metformin.
Approval Date: 13.11.2019
162. Glycopyrronium Inhalation Solution 25 mcg (For Nebulization) (Additional Dosage Form)
Composition: Each 2 ml contains Glycopyrrolate equivalent to Glycopyrronium 25 mcg in isotonic solution.
Indication: For long-term maintenance treatment of airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema.
Approval Date: 14.11.2019
163. Abemaciclib Film-Coated Tablets 50 mg / 100 mg / 150 mg / 200 mg
Composition: Abemaciclib 50 mg, 100 mg, 150 mg, and 200 mg film-coated tablets.
Indication:
• HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with endocrine therapy.
• Monotherapy in advanced or metastatic breast cancer after endocrine therapy and prior chemotherapy.
Approval Date: 18.11.2019
164. Formoterol Fumarate + Glycopyrronium Inhalation Aerosol (Additional Strength)
Composition (Per Actuation):
• Formoterol Fumarate Dihydrate IP – 5 mcg
• Glycopyrronium USP – 7.2 mcg
Indication: Maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.
Approval Date: 20.11.2019
165. Ripasudil Hydrochloride Hydrate Bulk Drug and Ripasudil Eye Drops 0.4% w/v
Composition: Ripasudil Eye Drops 0.4% w/v.
Indication: For the treatment of glaucoma and ocular hypertension when other glaucoma medicines are insufficient or cannot be used.
Approval Date: 20.11.2019
166. Diperoxochloric Acid Concentrate and Diperoxochloric Acid Topical Solution
Composition: Diperoxochloric Acid Concentrate and Topical Solution.
Indication: Indicated for wound healing in diabetic neuropathic ulcers of skin and subcutaneous tissues.
Approval Date: 20.11.2019
167. Cefpodoxime Proxetil Sustained Release Tablet 200 mg / 400 mg (Additional Dosage Form)
Composition: Each sustained-release tablet contains Cefpodoxime Proxetil equivalent to Cefpodoxime 200 mg or 400 mg.
Indication: Acute bronchitis, chronic bronchitis exacerbations, pneumonia, sinusitis, recurrent chronic tonsillitis, pharyngitis, and acute otitis.
Approval Date: 03.12.2019
168. Ivermectin Topical Lotion 0.5% w/w
Composition: Each ml contains Ivermectin 0.5% w/w.
Indication: For topical treatment of head lice infestation in patients aged 6 months and older.
Approval Date: 03.12.2019
169. Lenvatinib Capsules 4 mg and 10 mg (Additional Indication)
Composition:
• Lenvatinib Mesylate 4.90 mg equivalent to Lenvatinib 4 mg
• Lenvatinib Mesylate 12.25 mg equivalent to Lenvatinib 10 mg
Indication: In combination with Everolimus for the treatment of advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy.
Warning: To be sold by prescription of an Oncologist only.
Approval Date: 04.12.2019
170. Bilastine Oral Solution 2.5 mg/ml (Additional Dosage Form)
Composition: Each ml contains Bilastine 2.5 mg.
Indication: Symptomatic treatment of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria in children aged 6–11 years weighing at least 20 kg.
Approval Date: 10.12.2019
171. Endoxifen Citrate Bulk Drug and Endoxifen Tablets 8 mg
Composition: Endoxifen Tablets 8 mg.
Indication: For acute treatment of manic episodes with or without mixed features of Bipolar I Disorder.
Approval Date: 10.12.2019
172. Azelnidipine Bulk Drug and Azelnidipine Tablets 16 mg
Composition: Azelnidipine 16 mg.
Indication: For treatment of Stage II Hypertension.
Approval Date: 10.12.2019
173. Genopep Bulk Drug and Genopep 0.05% w/w Cream
Composition: Genopep Cream 0.05% w/w.
Indication: Treatment of burn wounds, antimicrobial therapy, and scar prevention/reduction.
Approval Date: 11.12.2019
174. Pregabalin Extended Release Tablets 82.5 mg and 165 mg
Composition: Pregabalin Extended Release 82.5 mg / 165 mg.
Indication: For the treatment of peripheral neuropathic pain in adults.
Approval Date: 12.12.2019
175. Repaglinide + Voglibose Tablets
Composition:
• Repaglinide 0.5 mg + Voglibose 0.2 mg
• Repaglinide 0.5 mg + Voglibose 0.3 mg
• Repaglinide 1 mg + Voglibose 0.2 mg
• Repaglinide 1 mg + Voglibose 0.3 mg
Indication: For the treatment of Type 2 Diabetes Mellitus as an adjunct to diet and exercise.
Approval Date: 13.12.2019
176. Alalevonadifloxacin Mesylate Bulk Drug and Levonadifloxacin Tablets 500 mg
Composition: Levonadifloxacin Tablets 500 mg.
Indication: Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI), including diabetic foot infections and concurrent bacteremia caused by susceptible Gram-positive organisms.
Approval Date: 13.12.2019
177. Clobetasol Propionate Topical Foam 0.05% w/w (Additional Dosage Form)
Composition:
• Clobetasol Propionate – 0.05% w/w
• Phenoxyethanol – 1.0% w/w
Indication: Treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older.
Approval Date: 16.12.2019
178. Clobetasol Propionate Cream 0.025% w/w (Additional Strength)
Composition: Each gram contains Clobetasol Propionate 0.25 mg.
Indication: Treatment of moderate to severe plaque psoriasis in adults aged 18 years and older.
Approval Date: 16.12.2019
179. Midodrine Hydrochloride Bulk Drug
Composition: Midodrine Hydrochloride Bulk Drug.
Indication: Not specified in the provided document.
Approval Date: 26.12.2019
180. Lorlatinib Film-Coated Tablets 25 mg and 100 mg
Composition: Lorlatinib Film-Coated Tablets 25 mg and 100 mg.
Indication: For treatment of ALK fusion gene-positive unresectable advanced and/or recurrent non-small cell lung cancer with resistance or intolerance to ALK tyrosine kinase inhibitors.
Approval Date: 26.12.2019
181. Levonadifloxacin L-Arginine Tetrahydrate Bulk Drug and Levonadifloxacin Injection 800 mg/100 ml
Composition: Levonadifloxacin Injection 800 mg/100 ml.
Indication: Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI), including diabetic foot infections and concurrent bacteremia caused by susceptible Gram-positive organisms.
Approval Date: 30.12.2019
182. Betahistine Dihydrochloride Orally Disintegrating Strips 16 mg / 24 mg (New Dosage Form)
Composition: Each orally disintegrating strip contains Betahistine Dihydrochloride 16 mg or 24 mg.
Indication: Treatment of Ménière’s syndrome is characterized by tinnitus, vertigo and sensorineural hearing loss.
Approval Date: 02.01.2020
183. Posaconazole Gastro-Resistant Tablet 100 mg (Modified Release Dosage Form)
Composition: Each gastro-resistant tablet contains Posaconazole 100 mg.
Indication: Prophylaxis of invasive Aspergillus and Candida infections in severely immunocompromised patients, including HSCT recipients and patients with hematologic malignancies.
Warning: To be sold by retail on the prescription of a Specialist only.
Approval Date: 03.01.2020
184. Cidofovir Dihydrate Bulk Drug and Cidofovir Injection 75 mg/ml
Composition: Cidofovir Injection 75 mg/ml (5 ml single-use vial).
Indication: Treatment of CMV retinitis in adults with AIDS and without renal dysfunction.
Approval Date: 03.01.2020
185. Dacomitinib Tablets 15 mg / 30 mg / 45 mg
Composition: Dacomitinib Tablets 15 mg, 30 mg, and 45 mg.
Indication: First-line treatment of metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 L858R substitution mutations.
Approval Date: 03.01.2020
186. Alpelisib Film-Coated Tablets 50 mg / 150 mg / 200 mg
Composition: Alpelisib Film-Coated Tablets 50 mg, 150 mg, and 200 mg.
Indication: In combination with Fulvestrant for the treatment of HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer.
Approval Date: 03.01.2020
187. Pirfenidone Tablet 600 mg (Additional Strength)
Composition: Each film-coated tablet contains Pirfenidone 600 mg.
Indication: For the treatment of idiopathic pulmonary fibrosis.
Warning: To be sold by retail on the prescription of a Pulmonologist only.
Approval Date: 08.01.2020
188. Saroglitazar Tablet 2 mg / 4 mg (Additional Indication)
Composition: Each uncoated tablet contains Saroglitazar 2 mg or 4 mg.
Indication: Type 2 Diabetes Mellitus as an add-on therapy to Metformin.
Approval Date: 13.01.2020
189. Glimepiride + Voglibose + Metformin ER Tablet
Composition:
• Glimepiride IP – 1 mg / 2 mg
• Voglibose IP – 0.2 mg
• Metformin HCl ER – 500 mg
Indication: Third-line treatment of Type 2 Diabetes Mellitus when adequate glycemic control is not achieved with diet, exercise, monotherapy, or dual therapy.
Approval Date: 14.01.2020
190. Enzalutamide Soft Capsule 40 mg (Additional Indication)
Composition: Each soft capsule contains Enzalutamide 40 mg.
Indication: Treatment of adult men with metastatic castration-resistant prostate cancer after failure of androgen deprivation therapy.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 23.01.2020
191. Sildenafil + Dapoxetine Tablets
Composition:
• Sildenafil 100 mg + Dapoxetine 60 mg
• Sildenafil 50 mg + Dapoxetine 60 mg
• Sildenafil 50 mg + Dapoxetine 30 mg
Indication: Treatment of co-existing erectile dysfunction and premature ejaculation in men aged 18–64 years.
Approval Date: 10.02.2020
192. S(-) Amlodipine + Telmisartan Tablet
Composition:
• S(-) Amlodipine 5 mg + Telmisartán 40 mg
• S(-) Amlodipine 2.5 mg + Telmisartán 40 mg
Indication: Treatment of essential hypertension.
Approval Date: 14.02.2020
193. Isavuconazole Sulphate Capsules 100 mg
Composition: Isavuconazole Sulphate Capsules 100 mg.
Indication: Treatment of invasive aspergillosis and invasive mucormycosis in adults.
Approval Date: 14.02.2020
194. Canagliflozin Tablets 100 mg / 300 mg (Additional Indication)
Composition: Each film-coated tablet contains Canagliflozin 100 mg or 300 mg.
Indication: To reduce the risk of major adverse cardiovascular events in adults with Type 2 Diabetes Mellitus and established cardiovascular disease.
Approval Date: 17.02.2020
195. Norethisterone Acetate Controlled Release Tablet 10 mg
Composition: Each controlled-release tablet contains Norethisterone Acetate 10 mg.
Indication: To arrest bleeding in women with dysfunctional uterine bleeding due to hormonal imbalance.
Approval Date: 24.02.2020
196. Efonidipine Hydrochloride Ethanolate 20 mg + Telmisartan 40 mg
Composition:
• Efonidipine Hydrochloride Ethanolate – 20 mg
• Telmisartan – 40 mg
Indication: Management of Stage II Hypertension.
Approval Date: 24.02.2020
197. Lidocaine Hydrochloride 2% Solution (Additional Dosage Form)
Composition: Each mL contains Lidocaine Hydrochloride 20 mg.
Indication:
• Topical anesthesia of irritated or inflamed oral and pharyngeal mucosa.
• Reduction of gag reflex during dental impressions and radiographic procedures.
Approval Date: 25.02.2020
198. Itraconazole Capsule 200 mg (Additional Strength)
Composition: Each capsule contains Itraconazole 200 mg.
Indication: Treatment of onychomycosis of the toenail caused by susceptible fungal organisms.
Warning: To be sold by retail on the prescription of a Specialist only.
Approval Date: 03.03.2020
199. Nepafenac Ophthalmic Suspension 0.3% w/v (Additional Indication)
Composition: Each mL contains Nepafenac 3 mg.
Indication: Reduction in the risk of postoperative macular edema associated with cataract surgery in diabetic patients.
Warning: To be sold by retail on the prescription of an Ophthalmologist only.
Approval Date: 03.03.2020
200. Gliclazide ER 60 mg + Metformin ER 1000 mg Tablet
Composition:
• Gliclazide ER – 60 mg
• Metformin Hydrochloride ER – 1000 mg
Indication: Treatment of Type II Diabetes Mellitus where diet, exercise, and monotherapy do not provide adequate glycemic control.
Approval Date: 03.03.2020
201. Azelnidipine Tablets IP 8 mg
Composition: Azelnidipine Tablets IP 8 mg.
Indication: Treatment of Stage I Hypertension.
Approval Date: 04.03.2020
202. Bisoprolol Fumarate Tablet 1.25 mg (Additional Strength)
Composition: Each film-coated tablet contains Bisoprolol Fumarate 1.25 mg.
Indication: Treatment of Congestive Heart Failure (CHF).
Approval Date: 04.03.2020
203. Pirfenidone Tablets 267 mg / 801 mg (Additional Strength)
Composition: Each film-coated tablet contains Pirfenidone 267 mg or 801 mg.
Indication: Treatment of idiopathic pulmonary fibrosis.
Warning: To be sold by retail on the prescription of a Pulmonologist only.
Approval Date: 04.03.2020
204. Pegaspargase Injection 3750 IU/5 ml (Additional Indication)
Composition: Each 5 ml vial contains Pegaspargase 3750 IU.
Indication: First-line chemotherapeutic treatment of Acute Lymphoblastic Leukemia (ALL).
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 04.03.2020
205. Norethisterone Acetate Controlled Release Tablet 15 mg (Additional Strength)
Composition: Each controlled-release tablet contains Norethisterone Acetate 15 mg.
Indication: Treatment of Heavy Menstrual Bleeding (HMB) and Abnormal Uterine Bleeding (AUB) due to hormonal imbalance.
Warning: To be sold by retail on the prescription of a Gynecologist/Obstetrician only.
Approval Date: 09.03.2020
206. Estriol Tablets 1 mg / 2 mg (Additional Strength)
Composition: Each uncoated tablet contains Estriol 1 mg or 2 mg.
Indication: Treatment of estrogen deficiency symptoms associated with menopause.
Warning: To be sold by retail on the prescription of a Gynecologist only.
Approval Date: 09.03.2020
207. Busulfan Injection 60 mg/10 ml (Additional Strength)
Composition: Each 10 ml vial contains Busulfan 60 mg.
Indication: In combination with Cyclophosphamide as a conditioning regimen before allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 09.03.2020
208. Montelukast 10 mg + Bilastine 20 mg Bilayered Tablet
Composition:
• Montelukast Sodium equivalent to Montelukast – 10 mg
• Bilastine – 20 mg
Indication: Treatment of allergic rhinitis in adults.
Approval Date: 09.03.2020
209. Riboflavin Ophthalmic Solution 0.1%
Composition: Riboflavin Ophthalmic Solution 0.1%.
Indication: Treatment of keratoconus and corneal ectasia following refractive surgery.
Approval Date: 11.03.2020
210. Pixantrone 29 mg Powder for Concentrate for Solution for Infusion
Composition: Pixantrone 29 mg Powder for Concentrate for Solution for Infusion.
Indication: Third-line and fourth-line treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin's B-cell Lymphomas (NHL).
Approval Date: 11.03.2020
211. Bilastine 20 mg + Montelukast 10 mg Tablets (FDC)
Composition:
• Bilastine – 20 mg
• Montelukast – 10 mg
Indication: For the treatment of allergic rhinitis in adults.
Approval Date: 11.03.2020
212. Obeticholic Acid Bulk Drug and Obeticholic Acid Tablets 5 mg / 10 mg
Composition: Obeticholic Acid Tablets 5 mg and 10 mg.
Indication: Treatment of Primary Biliary Cholangitis (PBC) in combination with Ursodeoxycholic Acid (UDCA) or as monotherapy in patients unable to tolerate UDCA.
Approval Date: 11.03.2020
213. Isavuconazole (as Isavuconazonium Sulfate) 200 mg Powder for Concentrate for Solution for Infusion
Composition: Isavuconazole 200 mg for infusion.
Indication: Treatment of invasive aspergillosis and invasive mucormycosis in adults.
Approval Date: 11.03.2020
214. Ulipristal Acetate Tablet 30 mg (Additional Strength & Indication)
Composition: Each film-coated tablet contains Ulipristal Acetate 30 mg.
Indication: Emergency contraception within 120 hours (5 days) after unprotected sexual intercourse or contraceptive failure.
Warning: To be sold by retail on the prescription of a Gynaecologist only.
Approval Date: 11.03.2020
215. Canagliflozin Tablets 100 mg / 300 mg (Additional Indication)
Composition: Each film-coated tablet contains Canagliflozin 100 mg or 300 mg.
Indication: To reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with Type 2 Diabetes Mellitus and diabetic nephropathy.
Approval Date: 11.03.2020
216. Metoprolol ER + Telmisartan + Chlorthalidone Tablet
Composition:
• Metoprolol Succinate ER 25 mg / 50 mg
• Telmisartan 40 mg
• Chlorthalidone 12.5 mg
Indication: Treatment of essential hypertension with stable coronary artery disease.
Approval Date: 17.03.2020
217. Nintedanib Soft Gelatin Capsules 100 mg / 150 mg (Additional Indication)
Composition: Nintedanib 100 mg / 150 mg Soft Gelatin Capsules.
Indication: Treatment of Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD).
Warning: To be sold by retail on the prescription of a Pulmonologist only.
Approval Date: 20.03.2020
218. Polymyxin B for Injection 500,000 IU
Composition: Polymyxin B Sulfate for Injection 500,000 IU.
Indication: Treatment of serious infections of the urinary tract, meninges, bloodstream, and eye caused by susceptible organisms, including Pseudomonas aeruginosa, E. coli, Klebsiella pneumoniae, and Haemophilus influenzae.
Approval Date: 30.03.2020
219. Glycopyrronium + Formoterol + Fluticasone Dry Powder Inhalation
Composition:
• Glycopyrronium – 12.5 mcg
• Formoterol Fumarate – 12 mcg
• Fluticasone Propionate – 250 mcg
Indication: Maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.
Approval Date: 16.04.2020
220. Sucroferric Oxyhydroxide Bulk Drug and Chewable Tablet 500 mg
Composition: Sucroferric Oxyhydroxide Chewable Tablet 500 mg.
Indication: Phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.
Approval Date: 18.04.2020
221. Sodium Hyaluronate + Polyethylene Glycol + Propylene Glycol Lubricant Eye Drops
Composition:
• Sodium Hyaluronate – 0.15% w/v
• Polyethylene Glycol 400 – 0.4% w/v
• Propylene Glycol – 0.3% w/v
Indication: Temporary relief of burning and irritation due to dry eye and for lubricating soft contact lenses.
Approval Date: 22.04.2020
222. Azilsartan Medoxomil + Cilnidipine Tablet
Composition:
• Azilsartan Medoxomil 40 mg
• Cilnidipine 5 mg / 10 mg
Indication: Treatment of Stage II Hypertension.
Approval Date: 24.04.2020
223. Capecitabine + Cyclophosphamide Tablet
Composition:
• Capecitabine 400 mg / 700 mg
• Cyclophosphamide 20 mg / 30 mg
Indication: Treatment of metastatic breast cancer after failure of prior anthracycline and/or taxane chemotherapy.
Approval Date: 28.04.2020
224. Hydrogen Peroxide 0.5% w/w Wipes
Composition: Hydrogen Peroxide 0.5% w/w.
Indication: Cleans, disinfects, and deodorizes hard non-porous environmental surfaces.
Approval Date: 29.04.2020
225. Oxaliplatin Injection 50 mg/Vial & 100 mg/Vial (Additional Dosage Form)
Composition: Sterile Oxaliplatin Solution 50 mg and 100 mg per vial.
Indication: Treatment of advanced colorectal cancer.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 29.04.2020
226. Tropicamide + Phenylephrine + Lidocaine Intracameral Injection
Composition (per ml):
• Tropicamide – 0.2 mg
• Phenylephrine Hydrochloride – 3.1 mg
• Lidocaine Hydrochloride – 10 mg
Indication: For cataract surgery, to obtain mydriasis and intraocular anesthesia during surgical procedures.
Approval Date: 04.05.2020
227. Metformin Hydrochloride Prolonged Release Tablets 500 mg (Additional Indication)
Composition: Metformin Hydrochloride Prolonged Release 500 mg.
Indication: Treatment of Polycystic Ovary Syndrome (PCOS) with established insulin resistance.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Approval Date: 05.05.2020
228. Olaparib Tablets 100 mg / 150 mg (Additional Indication)
Composition: Olaparib 100 mg and 150 mg tablets.
Indication: Maintenance treatment of adult patients with germline BRCA-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed after first-line platinum-based chemotherapy.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 06.05.2020
229. Bortezomib for Injection 2.5 mg/ml (Additional Pack Size)
Composition: Each vial contains Bortezomib 2.5 mg.
Indication:
• Treatment of Multiple Myeloma.
• Treatment of Mantle Cell Lymphoma after at least one prior therapy.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 12.05.2020
230. Centhaquine Citrate Bulk Drug and Centhaquine Citrate Injection 1 mg/Vial
Composition: Centhaquine Citrate Injection 1 mg/vial.
Indication: Add-on resuscitative agent for hypovolemic shock.
Approval Date: 15.05.2020
231. MultiBic Potassium-Free Solution for Haemodialysis / Haemofiltration
Composition: Contains glucose, magnesium chloride, calcium chloride, sodium bicarbonate, and sodium chloride in specified concentrations.
Indication: Used as a substitution solution in haemofiltration and haemodiafiltration, and as a dialysis solution in haemodialysis.
Approval Date: 15.05.2020
232. MultiBic 2 mmol/L & 4 mmol/L Potassium Solution for Haemodialysis / Haemofiltration
Composition: Contains potassium chloride, sodium chloride, sodium bicarbonate, calcium chloride, magnesium chloride, and glucose.
Indication: Used as a substitution solution in haemofiltration and haemodiafiltration, and as dialysis solution in haemodialysis.
Approval Date: 15.05.2020
233. Alogliptin + Metformin Tablets
Composition:
• Alogliptin 12.5 mg
• Metformin Hydrochloride 500 mg / 1000 mg
Indication: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 Diabetes Mellitus.
Approval Date: 18.05.2020
234. Fluticasone Furoate + Umeclidinium + Vilanterol Inhalation Powder
Composition:
• Fluticasone Furoate – 100 mcg
• Umeclidinium – 62.5 mcg
• Vilanterol – 25 mcg
Indication: Maintenance treatment to prevent and relieve symptoms associated with Chronic Obstructive Pulmonary Disease (COPD).
Approval Date: 18.05.2020
235. Phosphate-Based Solution for Haemodialysis or Haemofiltration
Composition: Contains Disodium Phosphate Dihydrate, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride, and Magnesium Chloride.
Indication: For haemodialysis and haemofiltration procedures.
Approval Date: 18.05.2020
236. Regiocit Solution for Haemofiltration
Composition:
• Sodium Citrate – 5.29 g/L
• Sodium Chloride – 5.03 g/L
Indication: Replacement fluid for Continuous Renal Replacement Therapy (CRRT) using regional citrate anticoagulation.
Approval Date: 21.05.2020
237. Hydrogen Peroxide 0.5% w/w Spray
Composition: Hydrogen Peroxide 0.5% w/w Spray.
Indication: Cleans, disinfects, and deodorizes hard non-porous environmental surfaces.
Approval Date: 28.05.2020
238. Ticagrelor 90 mg + Aspirin 75 mg Kit
Composition:
• Ticagrelor Tablets 90 mg
• Aspirin Gastro-resistant Tablets 75 mg
Indication: Prevention of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS), including PCI and CABG patients.
Approval Date: 29.05.2020
239. Remdesivir Injection 5 mg/ml and Lyophilised Powder for Injection 100 mg
Composition: Remdesivir Injection 5 mg/ml and Remdesivir Powder for Injection 100 mg.
Indication: Restricted emergency use for treatment of hospitalized adults and children with severe COVID-19.
Approval Date: 01.06.2020
240. Lymphoseek 50 mcg Kit (Tilmanocept)
Composition: Each kit contains Tilmanocept 50 mcg along with Glycine, Sodium Ascorbate, Trehalose Dihydrate, and other excipients.
Indication: Lymphatic mapping and sentinel lymph node identification procedures.
Approval Date: 05.06.2020
241. Baricitinib Tablets 1 mg / 2 mg / 4 mg (Additional Indication)
Composition: Baricitinib Tablets 1 mg, 2 mg, and 4 mg.
Indication: Treatment of moderate to severe Atopic Dermatitis in adult patients who are candidates for systemic therapy.
Approval Date: 08.06.2020
242. Crizotinib Capsules 200 mg and 250 mg (Additional Indication)
Composition: Crizotinib Capsules 200 mg and 250 mg.
Indication: Treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors are ROS1-positive.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 08.06.2020
243. Ticagrelor Tablets 60 mg (Additional Indication)
Composition: Each film-coated tablet contains Ticagrelor 60 mg.
Indication: Reduction of risk of cardiovascular death, myocardial infarction, and stroke in patients with a history of myocardial infarction and high-risk cardiovascular profile.
Approval Date: 08.06.2020
244. Favipiravir Tablets 200 mg
Composition: Each film-coated tablet contains Favipiravir 200 mg.
Indication: Restricted emergency use for treatment of mild to moderate COVID-19 disease.
Approval Date: 19.06.2020
245. Riociguat Tablets 0.5 mg / 1 mg / 1.5 mg / 2 mg / 2.5 mg
Composition: Riociguat Tablets in strengths of 0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg.
Indication: Treatment of Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Warning: To be sold by retail on the prescription of a Cardiologist or Pulmonologist only.
Approval Date: 22.06.2020
246. Deflazacort Oral Suspension 30 mg/5 ml
Composition: Each 5 ml contains Deflazacort 30 mg.
Indication: Treatment of Duchenne Muscular Dystrophy (DMD) in patients aged 5 years and older.
Approval Date: 22.06.2020
247. Bempedoic Acid Tablets 180 mg
Composition: Each film-coated tablet contains Bempedoic Acid 180 mg.
Indication: Adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease requiring additional LDL-C lowering.
Approval Date: 22.06.2020
248. Empagliflozin 12.5 mg + Metformin SR 500 mg / 1000 mg Tablets
Composition:
• Empagliflozin – 12.5 mg
• Metformin Hydrochloride SR – 500 mg / 1000 mg
Indication: Improvement of glycemic control in adults with Type 2 Diabetes Mellitus as an adjunct to diet and exercise.
Approval Date: 23.06.2020
249. Darolutamide Tablets 300 mg
Composition: Each film-coated tablet contains Darolutamide 300 mg.
Indication: Treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 24.06.2020
250. Cefixime Oral Suspension 50 mg/5 ml and 100 mg/5 ml (Additional Strength)
Composition: Cefixime Oral Suspension 50 mg/5 ml and 100 mg/5 ml.
Indication: Treatment of susceptible bacterial infections, including respiratory tract, urinary tract, and ENT infections.
Approval Date: 24.06.2020
251. Ripretinib Tablets 50 mg
Composition: Each tablet contains Ripretinib 50 mg.
Indication: Treatment of adult patients with advanced Gastrointestinal Stromal Tumor (GIST) who have received prior treatment with three or more kinase inhibitors.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 29.06.2020
252. Luliconazole Lotion 1% w/v (Additional Dosage Form)
Composition: Each mL contains Luliconazole 1% w/v.
Indication: Treatment of superficial fungal infections, including tinea corporis, tinea cruris, and tinea pedis.
Approval Date: 29.06.2020
253. Amisulpride Injection 5 mg/2 ml
Composition: Each 2 ml ampoule contains Amisulpride 5 mg.
Indication: Prevention and treatment of postoperative nausea and vomiting (PONV).
Approval Date: 01.07.2020
254. Prasugrel Tablets 5 mg and 10 mg (Additional Indication)
Composition: Prasugrel Tablets 5 mg and 10 mg.
Indication: Reduction of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS) undergoing Percutaneous Coronary Intervention (PCI).
Approval Date: 01.07.2020
255. Ferric Citrate Tablets 1 g
Composition: Each tablet contains Ferric Citrate 1 g.
Indication: Control of serum phosphorus levels in patients with chronic kidney disease on dialysis.
Approval Date: 01.07.2020
256. Trastuzumab Emtansine Lyophilized Powder for Injection 100 mg / 160 mg
Composition: Trastuzumab Emtansine for Injection 100 mg and 160 mg.
Indication: Treatment of HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 03.07.2020
257. Delamanid Tablets 25 mg and 50 mg (Additional Indication)
Composition: Delamanid Tablets 25 mg and 50 mg.
Indication: Treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) as part of an appropriate combination regimen.
Approval Date: 06.07.2020
258. Dapagliflozin Tablets 5 mg / 10 mg (Additional Indication)
Composition: Dapagliflozin Tablets 5 mg and 10 mg.
Indication: Treatment of Heart Failure with Reduced Ejection Fraction (HFrEF) in adults.
Approval Date: 08.07.2020
259. Favipiravir Tablets 400 mg (Additional Strength)
Composition: Each film-coated tablet contains Favipiravir 400 mg.
Indication: Restricted emergency use for treatment of mild to moderate COVID-19 disease.
Approval Date: 10.07.2020
260. Brentuximab Vedotin Powder for Injection 50 mg
Composition: Each vial contains Brentuximab Vedotin 50 mg.
Indication: Treatment of relapsed or refractory Hodgkin Lymphoma and systemic Anaplastic Large Cell Lymphoma.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 13.07.2020
261. Ticagrelor Tablets 90 mg (Additional Indication)
Composition: Each film-coated tablet contains Ticagrelor 90 mg.
Indication: Reduction of risk of cardiovascular death, myocardial infarction, and stroke in patients with Acute Coronary Syndrome.
Approval Date: 15.07.2020
262. Sacubitril + Valsartan Tablets 24/26 mg, 49/51 mg, and 97/103 mg (Additional Indication)
Composition: Sacubitril/Valsartan Tablets in approved strengths.
Indication: Treatment of symptomatic chronic heart failure with reduced ejection fraction.
Approval Date: 15.07.2020
263. Prucalopride Tablets 1 mg and 2 mg (Additional Indication)
Composition: Prucalopride Tablets 1 mg and 2 mg.
Indication: Symptomatic treatment of chronic constipation in adults where laxatives fail to provide adequate relief.
Approval Date: 16.07.2020
264. Belantamab Mafodotin Powder for Concentrate for Solution for Infusion 100 mg
Composition: Belantamab Mafodotin 100 mg.
Indication: Treatment of relapsed or refractory multiple myeloma in adult patients who have received at least four prior therapies.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 17.07.2020
265. Patiromer Sorbitex Calcium Powder for Oral Suspension
Composition: Patiromer Sorbitex Calcium Powder for Oral Suspension.
Indication: Treatment of hyperkalemia in adult patients.
Approval Date: 17.07.2020
266. Avatrombopag Tablets 20 mg
Composition: Each tablet contains Avatrombopag 20 mg.
Indication: Treatment of thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure.
Approval Date: 17.07.2020
267. Sodium Zirconium Cyclosilicate Powder for Oral Suspension 5 g and 10 g
Composition: Sodium Zirconium Cyclosilicate 5 g and 10 g sachets.
Indication: Treatment of hyperkalemia in adults.
Approval Date: 17.07.2020
268. Selpercatinib Capsules 40 mg and 80 mg
Composition: Selpercatinib Capsules 40 mg and 80 mg.
Indication: Treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC) in adults.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 20.07.2020
269. Nintedanib Soft Gelatin Capsules 100 mg / 150 mg (Additional Indication)
Composition: Nintedanib 100 mg and 150 mg Soft Gelatin Capsules.
Indication: Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
Warning: To be sold by retail on the prescription of a Pulmonologist only.
Approval Date: 20.07.2020
270. Artesunate Injection 60 mg
Composition: Each vial contains Artesunate 60 mg for Injection.
Indication: Initial treatment of severe malaria in adults and children.
Approval Date: 22.07.2020
271. Risdiplam Powder for Oral Solution 0.75 mg/ml
Composition: Each mL of reconstituted solution contains Risdiplam 0.75 mg.
Indication: Treatment of Spinal Muscular Atrophy (SMA) in patients 2 months of age and older.
Warning: To be sold by retail on the prescription of a Neurologist only.
Approval Date: 24.07.2020
272. Crizotinib Capsules 200 mg and 250 mg (Additional Indication)
Composition: Crizotinib Capsules 200 mg and 250 mg.
Indication: Treatment of adult patients with metastatic NSCLC whose tumors are ALK-positive.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 27.07.2020
273. Netarsudil Ophthalmic Solution 0.02% w/v
Composition: Each mL contains Netarsudil 0.2 mg.
Indication: Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Warning: To be sold by retail on the prescription of an Ophthalmologist only.
Approval Date: 27.07.2020
274. Tucatinib Tablets 50 mg and 150 mg
Composition: Tucatinib Tablets 50 mg and 150 mg.
Indication: In combination with Trastuzumab and Capecitabine for the treatment of advanced unresectable or metastatic HER2-positive breast cancer.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 29.07.2020
275. Ponesimod Tablets 2 mg / 3 mg / 4 mg / 5 mg / 6 mg / 7 mg / 8 mg / 9 mg / 10 mg / 20 mg
Composition: Ponesimod Tablets in approved strengths.
Indication: Treatment of relapsing forms of Multiple Sclerosis (MS) in adults.
Approval Date: 29.07.2020
276. Crizotinib Capsules 200 mg and 250 mg (Additional Indication)
Composition: Crizotinib Capsules 200 mg and 250 mg.
Indication: Treatment of pediatric patients and young adults with relapsed or refractory ALK-positive Anaplastic Large Cell Lymphoma (ALCL).
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 29.07.2020
277. Crizotinib Capsules 200 mg and 250 mg (Additional Indication)
Composition: Crizotinib Capsules 200 mg and 250 mg.
Indication: Treatment of unresectable, recurrent, or refractory inflammatory myofibroblastic tumors (IMT) that are ALK-positive.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 29.07.2020
278. Elexacaftor + Tezacaftor + Ivacaftor Tablets and Ivacaftor Tablets
Composition:
• Elexacaftor 100 mg
• Tezacaftor 50 mg
• Ivacaftor 75 mg
• Additional Ivacaftor Tablet 150 mg
Indication: Treatment of Cystic Fibrosis in patients aged 12 years and older with at least one F508del mutation in the CFTR gene.
Approval Date: 30.07.2020
279. Selumetinib Capsules 10 mg and 25 mg
Composition: Selumetinib Capsules 10 mg and 25 mg.
Indication: Treatment of pediatric patients aged 2 years and older with symptomatic, inoperable Plexiform Neurofibromas associated with Neurofibromatosis Type 1 (NF1).
Approval Date: 30.07.2020
280. Gilteritinib Tablets 40 mg
Composition: Each tablet contains Gilteritinib 40 mg.
Indication: Treatment of relapsed or refractory Acute Myeloid Leukemia (AML) with FLT3 mutation.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 30.07.2020
281. Dapagliflozin Tablets 5 mg and 10 mg (Additional Indication)
Composition: Dapagliflozin Tablets 5 mg and 10 mg.
Indication: Treatment of Chronic Kidney Disease (CKD) in adults at risk of progression.
Approval Date: 03.08.2020
282. Selpercatinib Capsules 40 mg and 80 mg (Additional Indication)
Composition: Selpercatinib Capsules 40 mg and 80 mg.
Indication: Treatment of RET-mutant Medullary Thyroid Cancer (MTC) requiring systemic therapy.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 03.08.2020
283. Selpercatinib Capsules 40 mg and 80 mg (Additional Indication)
Composition: Selpercatinib Capsules 40 mg and 80 mg.
Indication: Treatment of RET fusion-positive Thyroid Cancer requiring systemic therapy and radioactive iodine-refractory disease.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 03.08.2020
284. Bempedoic Acid 180 mg + Ezetimibe 10 mg Tablets
Composition:
• Bempedoic Acid – 180 mg
• Ezetimibe – 10 mg
Indication: Adjunct to diet and maximally tolerated statin therapy to reduce LDL cholesterol in adults with heterozygous familial hypercholesterolemia or established cardiovascular disease.
Approval Date: 05.08.2020
285. Favipiravir Tablets 200 mg (Additional Manufacturer Approval)
Composition: Each film-coated tablet contains Favipiravir 200 mg.
Indication: Restricted emergency use for treatment of mild to moderate COVID-19 disease.
Approval Date: 06.08.2020
286. Inclisiran Injection 284 mg/1.5 ml
Composition: Each prefilled syringe contains Inclisiran Sodium equivalent to Inclisiran 284 mg.
Indication: Adjunct to diet and statin therapy for treatment of adults with primary hyperlipidemia or mixed dyslipidemia.
Approval Date: 06.08.2020
287. Trilaciclib for Injection 300 mg
Composition: Trilaciclib 300 mg Lyophilized Powder for Injection.
Indication: To decrease the incidence of chemotherapy-induced myelosuppression in adult patients receiving chemotherapy for extensive-stage Small Cell Lung Cancer (ES-SCLC).
Approval Date: 07.08.2020
288. Sacituzumab Govitecan Lyophilized Powder for Injection 180 mg
Composition: Sacituzumab Govitecan 180 mg.
Indication: Treatment of metastatic Triple-Negative Breast Cancer (mTNBC) in adults who have received at least two prior therapies.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 07.08.2020
289. Berotralstat Capsules 150 mg
Composition: Each capsule contains Berotralstat Hydrochloride equivalent to Berotralstat 150 mg.
Indication: Prophylaxis to prevent attacks of Hereditary Angioedema (HAE) in adults and adolescents aged 12 years and older.
Approval Date: 10.08.2020
290. Fenfluramine Oral Solution 2.2 mg/ml
Composition: Each mL contains Fenfluramine 2.2 mg.
Indication: Treatment of seizures associated with Dravet Syndrome in patients aged 2 years and older.
Approval Date: 10.08.2020
291. Capmatinib Tablets 150 mg and 200 mg
Composition: Capmatinib Tablets 150 mg and 200 mg.
Indication: Treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) with MET exon 14 skipping mutation.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 10.08.2020
292. Belzutifan Tablets 40 mg
Composition: Each tablet contains Belzutifan 40 mg.
Indication: Treatment of patients with Von Hippel-Lindau (VHL) disease associated renal cell carcinoma, CNS hemangioblastomas,disease-associated or pancreatic neuroendocrine tumors.
Approval Date: 10.08.2020
293. Lumasiran Injection 94.5 mg/0.5 ml
Composition: Each 0.5 ml vial contains Lumasiran Sodium equivalent to Lumasiran 94.5 mg.
Indication: Treatment of Primary Hyperoxaluria Type 1 (PH1).
Approval Date: 11.08.2020
294. Margetuximab Injection 250 mg/10 ml
Composition: Each 10 ml vial contains Margetuximab 250 mg.
Indication: Treatment of metastatic HER2-positive breast cancer in adults who have received two or more prior anti-HER2 regimens.
Warning: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 11.08.2020
295. Umbralisib Tablets 200 mg
Composition: Each tablet contains Umbralisib 200 mg.
Indication: Treatment of relapsed or refractory Marginal Zone Lymphoma (MZL) after at least one prior anti-CD20-based regimen.
Approval Date: 12.08.2020
296. Melphalan Flufenamide Capsules 20 mg
Composition: Melphalan Flufenamide 20 mg.
Indication: Treatment of relapsed or refractory multiple myeloma in adults previously treated with multiple prior therapies.
Approval Date: 12.08.2020
297. Relugolix Tablets 120 mg
Composition: Each tablet contains Relugolix 120 mg.
Indication: Treatment of advanced prostate cancer in adult men.
Approval Date: 12.08.2020
298. Teprotumumab Injection 500 mg
Composition: Each vial contains Teprotumumab 500 mg.
Indication: Treatment of Thyroid Eye Disease (TED).
Approval Date: 13.08.2020
299. Vibegron Tablets 75 mg
Composition: Each tablet contains Vibegron 75 mg.
Indication: Treatment of Overactive Bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Approval Date: 13.08.2020
300. Evinacumab Injection 345 mg/2.3 ml
Composition: Each 2.3 ml vial contains Evinacumab-dgnb 345 mg.
Indication: Treatment of Homozygous Familial Hypercholesterolemia (HoFH) as an adjunct to other LDL-C lowering therapies.
Approval Date: 13.08.2020