India’s pharmaceutical industry continues to evolve rapidly, with new drug approvals playing a critical role in expanding treatment options across therapeutic segments. The approval of new drugs by the Central Drugs Standard Control Organization (CDSCO) ensures that medicines introduced into the Indian market meet regulatory standards for safety, efficacy, and quality. These approvals help healthcare professionals access innovative therapies while enabling pharmaceutical companies to address emerging medical needs.
This comprehensive list of CDSCO-approved drugs in India serves as a valuable reference for pharmaceutical manufacturers, healthcare providers, distributors, and regulatory professionals. The database covers approvals across multiple therapeutic areas, including oncology, cardiology, diabetes, infectious diseases, respiratory disorders, neurology, and rare diseases, reflecting the growing diversity of treatment options available to patients in India.
Sr. No. - Name of the Product - Composition - Indication - Date of Approval
301 Lidocaine Spray 10% w/v (Additional Strength)
Composition: Each ml contains:
- •Lidocaine – 100 mg
- •Ethanol – 30.4% v/v
- •Flavoured Base – q.s.
Indication: Prevention of pain associated with ENT procedures, obstetric procedures, endotracheal intubation, bronchoscopy, gastroscopy, and minor dental procedures.
Approval Date: 02.11.2020
302 Combipack of Favipiravir Tablets (Combipack)
Composition: Contains:
- •Favipiravir Tablets 200 mg (2 tablets)
- •Favipiravir Tablets 800 mg (16 tablets)
Indication:Restricted emergency use for treatment of patients with mild to moderate COVID-19 disease.
Approval Date: 27.11.2020
303 Rosuvastatin 20 mg + Clopidogrel 75 mg Tablets
Composition: Each film-coated tablet contains:
- •Rosuvastatin – 20 mg
- •Clopidogrel – 75 mg
Indication: Post-coronary intervention and acute coronary syndrome.
Approval Date: 27.11.2020
304 Remogliflozin Etabonate 100 mg + Vildagliptin 50 mg Tablets
Composition: Each film-coated tablet contains:
- •Remogliflozin Etabonate – 100 mg
- •Vildagliptin – 50 mg
Indication: For adults with Type 2 Diabetes Mellitus to improve glycaemic control.
Approval Date: 27.11.2020
305 Ivabradine + Metoprolol Tablets
Strengths:
- •7.5 mg + 25 mg
- •5 mg + 50 mg
- •5 mg + 25 mg
- •7.5 mg + 50 mg
Indication: Symptomatic treatment of chronic stable angina pectoris in adults already controlled on Ivabradine and Metoprolol.
Approval Date: 27.11.2020
306 Dapagliflozin 5 mg + Vildagliptin 50 mg + Metformin 500 mg Tablets (Additional Strength)
Composition:
- •Dapagliflozin – 5 mg
- •Vildagliptin – 50 mg
- •Metformin Hydrochloride – 500 mg
Indication: Management of Type 2 Diabetes Mellitus (T2DM).
Approval Date: 15.11.2023
307 Thyroxine Sodium Tablets 112 mcg (Additional Strength)
Composition: Each uncoated tablet contains:
- •Thyroxine Sodium – 112 mcg
Indication: Treatment of hypothyroidism.
Approval Date: 17.12.2020
308 Metoprolol + Chlorthalidone + Telmisartan Tablets
Strengths:
- •50 mg + 6.25 mg + 40 mg
- •25 mg + 6.25 mg + 40 mg
Indication: Treatment of uncontrolled essential hypertension and stable coronary artery disease (CAD).
Approval Date: 21.12.2020
309 Triamcinolone Acetonide Cream 0.1% w/w (New Dosage Form)
Composition: Each gram contains:
- •Triamcinolone Acetonide – 1 mg
- •Benzyl Alcohol – 2% w/w
- •Cream Base – q.s.
Indication: Inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Approval Date: 22.12.2020
310 Palbociclib Tablets 75 mg / 100 mg / 125 mg
Composition: Each film-coated tablet contains:
- •Palbociclib – 75 mg / 100 mg / 125 mg
Indication: Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with Fulvestrant or Letrozole.
Approval Date: December 2020
311 Lurasidone Hydrochloride Tablets 20 mg (Additional Strength)
Composition: Each film-coated tablet contains:
- •Lurasidone Hydrochloride – 20 mg
Indication: Treatment of patients with schizophrenia.
Approval Date: 24.12.2020
312 Hydrocortisone Sodium Succinate Injection 200 mg (Additional Strength)
Composition: Each vial contains:
- •Hydrocortisone Sodium Succinate (Buffered) equivalent to Hydrocortisone – 200 mg
Indication: Management of severe allergic disorders, dermatological diseases, endocrine disorders, gastrointestinal diseases, hematological disorders, respiratory diseases, rheumatic disorders, nephrotic syndrome, cerebral edema, leukemias, lymphomas, and other corticosteroid-responsive conditions.
Approval Date: 28.12.2020
313 Carvedilol 3.125 mg + Ivabradine 5 mg Tablets
Composition: Each film-coated tablet contains:
- •Carvedilol – 3.125 mg
- •Ivabradine – 5 mg
Indication: Substitution therapy in adult patients already controlled on Ivabradine and Carvedilol for:
- •Chronic stable angina pectoris
- •Chronic heart failure (NYHA Class II-IV) with systolic dysfunction
Approval Date: 30.12.2020
314 Adapalene 0.3% w/w + Benzoyl Peroxide 2.5% w/w Topical Gel (Additional Strength)
Composition: Each gram contains:
- •Adapalene – 0.3% w/w
- •Benzoyl Peroxide – 2.5% w/w
Indication: Cutaneous treatment of Acne Vulgaris with comedones, papules, and pustules.
Approval Date: 08.01.2021
315 Atropine Sulfate Ophthalmic Solution USP 0.01% w/v (Additional Strength)
Composition: Each ml contains:
- •Atropine Sulfate – 0.1 mg
- •Polyhexamethylene Biguanide Hydrochloride – 0.05 mg (Preservative)
Indication: Control of myopia progression in children aged 5 years and above.
Approval Date: January 2021
316 Bupivacaine Liposome Injectable Suspension 13.3 mg/ml
Composition: Each ml contains:
- •Bupivacaine (liposomal formulation) – 13.3 mg
Indication: Postsurgical local analgesia and pain management.
Approval Date: January 2021
317 Tofacitinib Extended Release Tablets 11 mg (Additional Dosage Form)
Composition: Each extended-release tablet contains:
- •Tofacitinib – 11 mg
Indication: Treatment of:
- •Rheumatoid Arthritis
- •Psoriatic Arthritis
- •Ulcerative Colitis
Approval Date: February 2021
318 Brivaracetam Oral Solution 10 mg/ml (Additional Dosage Form)
Composition: Each ml contains:
- •Brivaracetam – 10 mg
Indication: Adjunctive therapy in partial-onset seizures in epilepsy patients.
Approval Date: February 2021
319 Acalabrutinib Capsules 100 mg
Composition: Each capsule contains:
- •Acalabrutinib – 100 mg
Indication: Treatment of adult patients with:
- •Mantle Cell Lymphoma (MCL)
- •Chronic Lymphocytic Leukemia (CLL)
Approval Date: February 2021
320 Olaparib Tablets 100 mg / 150 mg
Composition: Each film-coated tablet contains:
- •Olaparib – 100 mg / 150 mg
Indication: Treatment of BRCA-mutated ovarian, breast, pancreatic, and prostate cancers.
Approval Date: February 2021
321 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 lowering LDL cholesterol in adults with hypercholesterolemia.
Approval Date: February 2021
322 Carfilzomib for Injection 60 mg
Composition: Each vial contains:
- •Carfilzomib – 60 mg
Indication: Treatment of patients with relapsed or refractory multiple myeloma.
Approval Date: February 2021
323 Ruxolitinib Tablets 5 mg / 10 mg / 15 mg / 20 mg
Composition: Each tablet contains:
- •Ruxolitinib – 5 mg / 10 mg / 15 mg / 20 mg
Indication: Treatment of:
- •Intermediate or high-risk Myelofibrosis
- •Polycythemia Vera resistant or intolerant to Hydroxyurea
Approval Date: February 2021
324 Bictegravir + Emtricitabine + Tenofovir Alafenamide Tablets
Composition: Each film-coated tablet contains:
- •Bictegravir – 50 mg
- •Emtricitabine – 200 mg
- •Tenofovir Alafenamide – 25 mg
Indication: Treatment of HIV-1 infection in adults and pediatric patients.
Approval Date: March 2021
325 Abemaciclib Tablets 50 mg / 100 mg / 150 mg / 200 mg
Composition: Each tablet contains:
- •Abemaciclib – 50 mg / 100 mg / 150 mg / 200 mg
Indication: Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer.
Approval Date: March 2021
326 Isavuconazole Capsules 100 mg
Composition: Each hard gelatin capsule contains:
- •Isavuconazole – 100 mg
Indication: Treatment of invasive aspergillosis and invasive mucormycosis.
Approval Date: March 2021
327 Sacubitril + Valsartan Tablets (Additional Strength)
Strengths:
- •24 mg + 26 mg
- •49 mg + 51 mg
- •97 mg + 103 mg
Indication: Treatment of chronic heart failure with reduced ejection fraction.
Approval Date: March 2021
328 Tofacitinib Tablets 10 mg (Additional Indication)
Composition: Each film-coated tablet contains:
- •Tofacitinib – 10 mg
Indication: Treatment of moderately to severely active Ulcerative Colitis in adults.
Approval Date: March 2021
329 Tedizolid Phosphate Tablets 200 mg
Composition: Each film-coated tablet contains:
- •Tedizolid Phosphate – 200 mg
Indication: Treatment of acute bacterial skin and skin structure infections (ABSSSI).
Approval Date: March 2021
330 Rivaroxaban Tablets 2.5 mg (Additional Strength)
Composition: Each film-coated tablet contains:
- •Rivaroxaban – 2.5 mg
Indication: Reduction of major cardiovascular events in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD).
Approval Date: March 2021
331 Lasmiditan Tablets 50 mg / 100 mg
Composition: Each film-coated tablet contains:
- •Lasmiditan – 50 mg / 100 mg
Indication: Acute treatment of migraine with or without aura in adults.
Approval Date: March 2021
332 Budesonide Rectal Foam 2 mg
Composition: Each metered dose contains:
- •Budesonide – 2 mg
Indication: Induction of remission in patients with active mild to moderate distal ulcerative colitis.
Approval Date: March 2021
333 Finerenone Tablets 10 mg / 20 mg
Composition: Each film-coated tablet contains:
- •Finerenone – 10 mg / 20 mg
Indication: Treatment of chronic kidney disease associated with Type 2 Diabetes Mellitus.
Approval Date: March 2021
334 Selpercatinib Capsules 40 mg / 80 mg
Composition: Each capsule contains:
- •Selpercatinib – 40 mg / 80 mg
Indication: Treatment of RET fusion-positive non-small cell lung cancer and RET-mutant thyroid cancers.
Approval Date: March 2021
335 Empagliflozin 12.5 mg + Metformin Hydrochloride 500 mg / 1000 mg Tablets
Composition: Each film-coated tablet contains:
- •Empagliflozin – 12.5 mg
- •Metformin Hydrochloride – 500 mg / 1000 mg
Indication: Improvement of glycemic control in adults with Type 2 Diabetes Mellitus.
Approval Date: March 2021
336 Ripretinib Tablets 50 mg
Composition: Each tablet contains:
- •Ripretinib – 50 mg
Indication: Treatment of advanced gastrointestinal stromal tumor (GIST) after prior kinase inhibitor therapy.
Approval Date: March 2021
337 Avatrombopag Tablets 20 mg
Composition: Each tablet contains:
- •Avatrombopag – 20 mg
Indication: Treatment of thrombocytopenia in adults with chronic liver disease scheduled for a procedure and chronic immune thrombocytopenia.
Approval Date: March 2021
338 Dapagliflozin Tablets 10 mg (Additional Indication)
Composition: Each film-coated tablet contains:
- •Dapagliflozin – 10 mg
Indication: Reduction of risk of hospitalization for heart failure and cardiovascular death in adults with heart failure.
Approval Date: March 2021
339 Prasugrel Tablets 5 mg / 10 mg
Composition: Each film-coated tablet contains:
- •Prasugrel – 5 mg / 10 mg
Indication: Prevention of thrombotic cardiovascular events in patients with acute coronary syndrome undergoing PCI.
Approval Date: March 2021
340 Crizotinib Capsules 200 mg / 250 mg
Composition: Each capsule contains:
- •Crizotinib – 200 mg / 250 mg
Indication: Treatment of ALK-positive or ROS1-positive metastatic non-small cell lung cancer (NSCLC).
Approval Date: March 2021
341 Azilsartan Medoxomil 40 mg + Chlorthalidone 12.5 mg / 25 mg Tablets
Composition: Each tablet contains:
- •Azilsartan Medoxomil – 40 mg
- •Chlorthalidone – 12.5 mg / 25 mg
Indication: Treatment of essential hypertension in adults.
Approval Date: March 2021
342 Fostemsavir Extended Release Tablets 600 mg
Composition: Each extended-release tablet contains:
- •Fostemsavir – 600 mg
Indication: Treatment of multidrug-resistant HIV-1 infection in heavily treatment-experienced adults.
Approval Date: March 2021
343 Nintedanib Soft Gelatin Capsules 100 mg / 150 mg
Composition: Each soft gelatin capsule contains:
- •Nintedanib – 100 mg / 150 mg
Indication: Treatment of:
- •Idiopathic Pulmonary Fibrosis (IPF)
- •Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Approval Date: March 2021
344 Dolutegravir Dispersible Tablets 10 mg (Additional Dosage Form)
Composition: Each tablet contains:
- •Dolutegravir Sodium equivalent to Dolutegravir – 10 mg
Indication: In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients aged at least 4 weeks and weighing at least 3 kg.
Approval Date: 23.03.2021
345 Sildenafil Citrate Oral Spray 12.5% w/v (Additional Dosage Form)
Composition: Each spray (0.2 ml) delivers:
- •Sildenafil equivalent to Sildenafil Citrate – 25 mg
Indication: Treatment of Erectile Dysfunction in men.
Approval Date: 26.03.2021
346 Dexamethasone Tablets 6 mg (Additional Strength)
Composition: Each film-coated tablet contains:
- •Dexamethasone – 6 mg
Indication: Treatment of corticosteroid-responsive conditions, including:
- •Cerebral edema
- •Autoimmune disorders
- •Rheumatoid arthritis
- •Systemic lupus erythematosus
- •Hematological disorders
- •Leukemias and lymphomas
Approval Date: 06.04.2021
347 Betahistine Hydrochloride Orally Disintegrating Tablets 8 mg / 16 mg / 24 mg (New Dosage Form)
Composition: Each orally disintegrating tablet contains:
- •Betahistine Hydrochloride – 8 mg / 16 mg / 24 mg
Indication: Symptomatic treatment of vertigo associated with Meniere's syndrome.
Approval Date: 06.04.2021
348 Mirabegron + Solifenacin Succinate Bilayer Tablets
Strengths:
- •50 mg + 5 mg
- •25 mg + 5 mg
Composition: Each film-coated bilayer tablet contains:
- •Mirabegron (Extended Release)
- •Solifenacin Succinate
Indication: Treatment of Overactive Bladder (OAB).
Approval Date: 08.04.2021
349 Sodium Hyaluronate + Chondroitin Sulfate Sodium Oral Liquid Sachet
Composition (per 10 ml):
- •Sodium Hyaluronate – 1.24%
- •Chondroitin Sulfate Sodium – 3.12%
- •Poloxamer 407 – 2.7%
Indication: Management of osteoarthritis and joint-related disorders.
Approval Date: April 2021
350 Apalutamide Tablets 60 mg
Composition: Each film-coated tablet contains:
- •Apalutamide – 60 mg
Indication: Treatment of:
- •Non-metastatic castration-resistant prostate cancer (nmCRPC)
- •Metastatic castration-sensitive prostate cancer (mCSPC)
Approval Date: April 2021
351 Riociguat Tablets 0.5 mg / 1 mg / 1.5 mg / 2 mg / 2.5 mg
Composition: Each film-coated tablet contains:
- •Riociguat – 0.5 mg / 1 mg / 1.5 mg / 2 mg / 2.5 mg
Indication: Treatment of:
- •Pulmonary Arterial Hypertension (PAH)
- •Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Approval Date: April 2021
352 Empagliflozin 10 mg + Linagliptin 5 mg Tablets
Composition: Each film-coated tablet contains:
- •Empagliflozin – 10 mg
- •Linagliptin – 5 mg
Indication: Improvement of glycemic control in adults with Type 2 Diabetes Mellitus.
Approval Date: April 2021
353 Alectinib Capsules 150 mg
Composition: Each capsule contains:
- •Alectinib – 150 mg
Indication: Treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC).
Approval Date: April 2021
354 Insulin Aspart Injection 100 IU/ml (Prefilled Pen)
Composition: Each ml contains:
- •Insulin Aspart – 100 IU
Indication: Improvement of glycemic control in adults and children with diabetes mellitus.
Approval Date: April 2021
355 Vericiguat Tablets 2.5 mg / 5 mg / 10 mg
Composition: Each film-coated tablet contains:
- •Vericiguat – 2.5 mg / 5 mg / 10 mg
Indication: Treatment of symptomatic chronic heart failure in adults with reduced ejection fraction.
Approval Date: April 2021
356 Brolucizumab Solution for Injection 120 mg/ml
Composition: Each prefilled syringe contains:
- •Brolucizumab – 120 mg/ml
Indication: Treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD).
Approval Date: April 2021
357 Bictegravir 50 mg + Emtricitabine 200 mg + Tenofovir Alafenamide 25 mg Tablets
Composition: Each film-coated tablet contains:
- •Bictegravir – 50 mg
- •Emtricitabine – 200 mg
- •Tenofovir Alafenamide – 25 mg
Indication: Treatment of Human Immunodeficiency Virus Type-1 (HIV-1) infection.
Approval Date: April 2021
358 Dapagliflozin Tablets 5 mg / 10 mg (Additional Indication)
Composition: Each film-coated tablet contains:
- •Dapagliflozin – 5 mg / 10 mg
Indication: Treatment of Chronic Kidney Disease (CKD) and reduction in risk of kidney function decline.
Approval Date: May 2021
359 Alpha Ketoanalogue + Essential Amino Acid Tablets
Composition: Each film-coated tablet contains:
- •L-Histidine – 76 mg
- •L-Tryptophan – 46 mg
- •L-Threonine – 106 mg
- •L-Lysine Acetate – 210 mg
- •Alpha Ketoanalogues of Methionine, Valine, Phenylalanine, Leucine and Isoleucine
Indication: Prevention and treatment of protein metabolism disorders in Chronic Kidney Disease (CKD) patients on low-protein diets.
Approval Date: 18.05.2021
360 Favipiravir Oral Suspension 100 mg/ml(New Dosage Form)
Composition: Each ml contains:
- •Favipiravir – 100 mg
Indication: Treatment of patients with mild to moderate COVID-19 disease.
Approval Date: 19.05.2021
361 Icosapent Ethyl Capsules 500 mg / 1000 mg
Composition: Each soft gelatin capsule contains:
- •Icosapent Ethyl – 500 mg / 1000 mg
Indication: Adjunct to statin therapy for the reduction of cardiovascular risk in adults with elevated triglyceride levels.
Approval Date: May 2021
362 Ferric Carboxymaltose Injection 500 mg / 1000 mg
Composition: Each vial contains:
- •Ferric Carboxymaltose – 500 mg / 1000 mg
Indication: Treatment of iron deficiency anemia when oral iron preparations are ineffective or cannot be used.
Approval Date: May 2021
363 Remdesivir Lyophilized Powder for Injection 100 mg (Additional Manufacturing Source)
Composition: Each vial contains:
- •Remdesivir – 100 mg
Indication: Treatment of suspected or laboratory-confirmed COVID-19 infection in hospitalized adult and pediatric patients.
Approval Date: May 2021
364 Posaconazole Gastro-Resistant Tablets 100 mg
Composition: Each delayed-release tablet contains:
- •Posaconazole – 100 mg
Indication: Prophylaxis and treatment of invasive fungal infections in immunocompromised patients.
Approval Date: May 2021
365 Enzalutamide Capsules 40 mg
Composition: Each soft capsule contains:
- •Enzalutamide – 40 mg
Indication: Treatment of metastatic and non-metastatic castration-resistant prostate cancer.
Approval Date: May 2021
366 Lenvatinib Capsules 4 mg / 10 mg
Composition: Each capsule contains:
- •Lenvatinib – 4 mg / 10 mg
Indication: Treatment of:
- •Differentiated Thyroid Cancer
- •Hepatocellular Carcinoma
- •Renal Cell Carcinoma
Approval Date: May 2021
367 Baricitinib Tablets 2 mg / 4 mg (Additional Indication)
Composition: Each film-coated tablet contains:
- •Baricitinib – 2 mg / 4 mg
Indication: Treatment of hospitalized COVID-19 patients requiring supplemental oxygen, non-invasive or invasive mechanical ventilation.
Approval Date: June 2021
368 Empagliflozin Tablets 10 mg / 25 mg (Additional Indication)
Composition: Each film-coated tablet contains:
- •Empagliflozin – 10 mg / 25 mg
Indication: Reduction of cardiovascular death and hospitalization in adults with heart failure.
Approval Date: June 2021
369 Brigatinib Tablets 30 mg / 90 mg / 180 mg
Composition: Each film-coated tablet contains:
- •Brigatinib – 30 mg / 90 mg / 180 mg
Indication: Treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC).
Approval Date: June 2021
370 Risdiplam Powder for Oral Solution 0.75 mg/ml
Composition: After reconstitution, each mL contains:
- •Risdiplam – 0.75 mg
Indication: Treatment of Spinal Muscular Atrophy (SMA) in adults and pediatric patients.
Approval Date: June 2021
371 Ticagrelor Tablets 60 mg / 90 mg
Composition: Each film-coated tablet contains:
- •Ticagrelor – 60 mg / 90 mg
Indication: Reduction of cardiovascular death, myocardial infarction, and stroke in patients with Acute Coronary Syndrome (ACS) or a history of myocardial infarction.
Approval Date: June 2021
372 Dapagliflozin 10 mg + Saxagliptin 5 mg Tablets
Composition: Each film-coated tablet contains:
- •Dapagliflozin – 10 mg
- •Saxagliptin – 5 mg
Indication: Improvement of glycemic control in adults with Type 2 Diabetes Mellitus.
Approval Date: June 2021
373 Umifenovir Capsules 200 mg
Composition: Each capsule contains:
- •Umifenovir – 200 mg
Indication: Treatment of uncomplicated influenza virus infection and restricted use in mild COVID-19 cases as approved.
Approval Date: June 2021
374 Cabozantinib Tablets 20 mg / 40 mg / 60 mg
Composition: Each film-coated tablet contains:
- •Cabozantinib – 20 mg / 40 mg / 60 mg
Indication: Treatment of:
- •Renal Cell Carcinoma (RCC)
- •Hepatocellular Carcinoma (HCC)
- •Differentiated Thyroid Cancer (DTC)
Approval Date: June 2021
375 Atezolizumab Injection 1200 mg/20 ml
Composition: Each vial contains:
- •Atezolizumab – 1200 mg
Indication: Treatment of various malignancies, including:
- •Non-Small Cell Lung Cancer (NSCLC)
- •Small Cell Lung Cancer (SCLC)
- •Urothelial Carcinoma
Approval Date: June 2021
376 Empagliflozin 25 mg + Linagliptin 5 mg Tablets
Composition: Each film-coated tablet contains:
- •Empagliflozin – 25 mg
- •Linagliptin – 5 mg
Indication: Improvement of glycemic control in adults with Type 2 Diabetes Mellitus.
Approval Date: June 2021
377 Patiromer Powder for Oral Suspension
Strengths:
- •8.4 g
- •16.8 g
- •25.2 g
Composition: Each sachet contains:
- •Patiromer Sorbitex Calcium – Equivalent strength as labeled
Indication: Treatment of Hyperkalemia in adult patients.
Approval Date: June 2021
378 Acalabrutinib Capsules 100 mg (Additional Indication)
Composition: Each capsule contains:
- •Acalabrutinib – 100 mg
Indication: Treatment of:
- •Chronic Lymphocytic Leukemia (CLL)
- •Small Lymphocytic Lymphoma (SLL)
Approval Date: July 2021
379 Darolutamide Tablets 300 mg
Composition: Each film-coated tablet contains:
- •Darolutamide – 300 mg
Indication: Treatment of Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC).
Approval Date: July 2021
380 Mepolizumab Powder for Injection 100 mg
Composition: Each vial contains:
- •Mepolizumab – 100 mg
Indication: Add-on maintenance treatment of severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA).
Approval Date: July 2021
381 Trastuzumab Deruxtecan for Injection 100 mg
Composition: Each vial contains:
- •Trastuzumab Deruxtecan – 100 mg
Indication: Treatment of HER2-positive unresectable or metastatic breast cancer in adult patients who have received prior anti-HER2-based regimens.
Approval Date: July 2021
382 Abrocitinib Tablets 50 mg / 100 mg / 200 mg
Composition: Each film-coated tablet contains:
- •Abrocitinib – 50 mg / 100 mg / 200 mg
Indication: Treatment of moderate to severe Atopic Dermatitis in adults requiring systemic therapy.
Approval Date: July 2021
383 Breztri Aerosphere Inhalation Aerosol
Composition: Each delivered dose contains:
- •Budesonide – 160 mcg
- •Glycopyrrolate – 9 mcg
- •Formoterol Fumarate – 4.8 mcg
Indication: Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD).
Approval Date: July 2021
384 Semaglutide Tablets 3 mg / 7 mg / 14 mg
Composition: Each tablet contains:
- •Semaglutide – 3 mg / 7 mg / 14 mg
Indication: Improvement of glycemic control in adults with Type 2 Diabetes Mellitus.
Approval Date: July 2021
385 Amisulpride Injection 5 mg/2 ml
Composition: Each 2 ml ampoule contains:
- •Amisulpride – 5 mg
Indication: Prevention and treatment of Post-Operative Nausea and Vomiting (PONV).
Approval Date: July 2021
386 Empagliflozin Tablets 10 mg / 25 mg (Additional Indication)
Composition: Each film-coated tablet contains:
- •Empagliflozin – 10 mg / 25 mg
Indication: Treatment of Heart Failure with Reduced Ejection Fraction (HFrEF) in adults.
Approval Date: August 2021
387 Tislelizumab Injection 100 mg/10 ml
Composition: Each vial contains:
- •Tislelizumab – 100 mg
Indication: Treatment of recurrent or metastatic classical Hodgkin Lymphoma and other approved malignancies.
Approval Date: August 2021
388 Sacituzumab Govitecan Injection 180 mg
Composition: Each vial contains:
- •Sacituzumab Govitecan – 180 mg
Indication: Treatment of metastatic Triple-Negative Breast Cancer (mTNBC) in adult patients who have received prior therapies.
Approval Date: August 2021
389 Maribavir Tablets 200 mg
Composition: Each film-coated tablet contains:
- •Maribavir – 200 mg
Indication: Treatment of post-transplant Cytomegalovirus (CMV) infection or disease refractory to prior therapy.
Approval Date: August 2021
390 Belzutifan Tablets 40 mg
Composition: Each film-coated tablet contains:
- •Belzutifan – 40 mg
Indication: Treatment of adult patients with Von Hippel-Lindau (VHL) disease-associated renal cell carcinoma and related tumors requiring therapy.
Approval Date: August 2021
391 Relugolix Tablets 120 mg
Composition: Each film-coated tablet contains:
- •Relugolix – 120 mg
Indication: Treatment of advanced prostate cancer in adult men.
Approval Date: August 2021
392 Ponesimod Tablets 2 mg / 3 mg / 4 mg / 5 mg / 6 mg / 7 mg / 8 mg / 9 mg / 10 mg / 20 mg
Composition: Each film-coated tablet contains:
- •Ponesimod – As labeled
Indication: Treatment of relapsing forms of Multiple Sclerosis (MS) in adults.
Approval Date: August 2021
393 Evinacumab Injection 345 mg/2.3 ml
Composition: Each vial contains:
- •Evinacumab-dgnb – 345 mg/2.3 ml
Indication: Treatment of Homozygous Familial Hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering therapies.
Approval Date: August 2021
394 Melphalan Flufenamide Capsules 20 mg
Composition: Each capsule contains:
- •Melphalan Flufenamide – 20 mg
Indication: Treatment of relapsed or refractory Multiple Myeloma in combination with Dexamethasone.
Approval Date: August 2021
395 Empagliflozin + Metformin Hydrochloride Extended Release Tablets
Strengths:
- •10 mg + 500 mg
- •10 mg + 1000 mg
- •25 mg + 500 mg
- •25 mg + 1000 mg
Composition: Each extended-release tablet contains:
- •Empagliflozin – As labeled
- •Metformin Hydrochloride ER – As labeled
Indication: Improvement of glycemic control in adults with Type 2 Diabetes Mellitus.
Approval Date: September 2021
396 Aducanumab Injection 170 mg/1.7 ml & 300 mg/3 ml
Composition: Each vial contains:
- •Aducanumab – 100 mg/ml
Indication: Treatment of Alzheimer's Disease in patients with mild cognitive impairment or mild dementia stage.
Approval Date: September 2021
397 Tezepelumab Injection 210 mg/1.91 ml
Composition: Each prefilled syringe contains:
- •Tezepelumab-ekko – 210 mg/1.91 ml
Indication: Add-on maintenance treatment of severe asthma in adults and adolescents.
Approval Date: September 2021
398 Mobocertinib Capsules 40 mg
Composition: Each capsule contains:
- •Mobocertinib – 40 mg
Indication: Treatment of EGFR Exon 20 insertion mutation-positive metastatic Non-Small Cell Lung Cancer (NSCLC).
Approval Date: September 2021
399 Inclisiran Injection 284 mg/1.5 ml
Composition: Each prefilled syringe contains:
- •Inclisiran Sodium equivalent to Inclisiran – 284 mg/1.5 ml
Indication: Treatment of primary hyperlipidemia and mixed dyslipidemia to reduce LDL cholesterol levels.
Approval Date: September 2021
400 Atogepant Tablets 10 mg / 30 mg / 60 mg
Composition:Each tablet contains:
- •Atogepant – 10 mg / 30 mg / 60 mg
Indication:Preventive treatment of episodic migraine in adults.
Approval Date: September 2021
401 Lonapegsomatropin Injection 5.2 mg / 11 mg / 13.3 mg
Composition: Each single-dose cartridge contains:
- •Lonapegsomatropin-tcgd – As labeled
Indication: Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone.
Approval Date: September 2021
402 Sotorasib Tablets 120 mg
Composition: Each film-coated tablet contains:
- •Sotorasib – 120 mg
Indication: Treatment of KRAS G12C-mutated locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC).
Approval Date: September 2021
403 Empagliflozin 12.5 mg + Metformin Hydrochloride 500 mg / 1000 mg Tablets
Composition: Each film-coated tablet contains:
- •Empagliflozin – 12.5 mg
- •Metformin Hydrochloride – 500 mg / 1000 mg
Indication: Improvement of glycemic control in adults with Type 2 Diabetes Mellitus.
Approval Date: September 2021
404 Fosdenopterin Injection 9.5 mg
Composition: Each vial contains:
- •Fosdenopterin Hydrobromide equivalent to Fosdenopterin – 9.5 mg
Indication:Treatment of Molybdenum Cofactor Deficiency Type A (MoCD Type A).
Approval Date: September 2021
405 Efgartigimod Alfa Injection 400 mg/20 ml
Composition: Each vial contains:
- •Efgartigimod Alfa – 400 mg/20 ml
Indication: Treatment of generalized Myasthenia Gravis in adult patients who are anti-acetylcholine receptor antibody positive.
Approval Date: October 2021
406 Trilaciclib Injection 300 mg
Composition: Each vial contains:
- •Trilaciclib – 300 mg
Indication: Reduction of chemotherapy-induced myelosuppression in adult patients receiving chemotherapy for extensive-stage Small Cell Lung Cancer (SCLC).
Approval Date: October 2021
407 Finerenone Tablets 10 mg / 20 mg
Composition: Each film-coated tablet contains:
- •Finerenone – 10 mg / 20 mg
Indication: Reduction of risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with Chronic Kidney Disease associated with Type 2 Diabetes.
Approval Date: October 2021
408 Droxidopa Capsules 100 mg / 200 mg / 300 mg
Composition: Each capsule contains:
- •Droxidopa – 100 mg / 200 mg / 300 mg
Indication: Treatment of symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure, Parkinson’s disease, or multiple system atrophy.
Approval Date: October 2021
409 Melphalan Injection 50 mg
Composition: Each vial contains:
- •Melphalan Hydrochloride equivalent to Melphalan – 50 mg
Indication: Treatment of Multiple Myeloma and as a conditioning regimen before hematopoietic stem cell transplantation.
Approval Date: October 2021
410 Ripretinib Tablets 50 mg
Composition: Each tablet contains:
- •Ripretinib – 50 mg
Indication: Treatment of advanced Gastrointestinal Stromal Tumor (GIST) in adult patients who have received prior treatment with three or more kinase inhibitors.
Approval Date: October 2021
411 Asciminib Tablets 20 mg / 40 mg
Composition: Each film-coated tablet contains:
- •Asciminib – 20 mg / 40 mg
Indication: Treatment of adult patients with Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML) in chronic phase previously treated with two or more tyrosine kinase inhibitors.
Approval Date: October 2021
412 Odevixibat Capsules 200 mcg / 400 mcg / 600 mcg / 1200 mcg
Composition: Each capsule contains:
- •Odevixibat – As labeled
Indication: Treatment of pruritus in patients with Progressive Familial Intrahepatic Cholestasis (PFIC).
Approval Date: October 2021
413 Cabotegravir Extended Release Injection 400 mg/2 ml & 600 mg/3 ml
Composition: Each vial contains:
- •Cabotegravir – 400 mg/2 ml or 600 mg/3 ml
Indication: In combination with Rilpivirine for treatment of HIV-1 infection in virologically suppressed adults.
Approval Date: November 2021
414 Rilpivirine Extended Release Injection 600 mg/2 ml & 900 mg/3 ml
Composition: Each vial contains:
- •Rilpivirine – 600 mg/2 ml or 900 mg/3 ml
Indication: Used with Cabotegravir for long-acting maintenance treatment of HIV-1 infection.
Approval Date: November 2021
415 Tivozanib Capsules 0.89 mg / 1.34 mg
Composition: Each capsule contains:
- •Tivozanib Hydrochloride equivalent to Tivozanib – 0.89 mg / 1.34 mg
Indication: Treatment of relapsed or refractory advanced Renal Cell Carcinoma (RCC).
Approval Date: November 2021
416 Atogepant Tablets 10 mg / 30 mg / 60 mg
Composition: Each film-coated tablet contains:
- •Atogepant – 10 mg / 30 mg / 60 mg
Indication:Preventive treatment of episodic migraine in adults.
Approval Date: November 2021
417 Amlodipine 5 mg + Telmisartan 40 mg + Chlorthalidone 12.5 mg Tablets
Composition: Each tablet contains:
- •Amlodipine – 5 mg
- •Telmisartan – 40 mg
- •Chlorthalidone – 12.5 mg
Indication: Treatment of essential hypertension not adequately controlled with dual therapy.
Approval Date: November 2021
418 Maralixibat Oral Solution 9.5 mg/ml
Composition: Each ml contains:
- •Maralixibat Chloride equivalent to Maralixibat – 9.5 mg
Indication: Treatment of cholestatic pruritus in patients with Alagille Syndrome.
Approval Date: November 2021
419 Belumosudil Tablets 200 mg
Composition: Each film-coated tablet contains:
- •Belumosudil – 200 mg
Indication: Treatment of chronic Graft-Versus-Host Disease (cGVHD) after failure of at least two prior lines of systemic therapy.
Approval Date: November 2021
420 Infigratinib Capsules 25 mg
Composition: Each capsule contains:
- •Infigratinib – 25 mg
Indication: Treatment of previously treated, unresectable locally advanced or metastatic Cholangiocarcinoma with FGFR2 fusion or rearrangement.
Approval Date: November 2021
421 Tepotinib Tablets 225 mg
Composition: Each film-coated tablet contains:
- •Tepotinib Hydrochloride Hydrate equivalent to Tepotinib – 225 mg
Indication: Treatment of adult patients with metastatic Non-Small Cell Lung Cancer (NSCLC) harboring MET Exon 14 skipping alterations.
Approval Date: November 2021
422 Amlodipine 5 mg + Telmisartan 40 mg + Chlorthalidone 6.25 mg Tablets
Composition: Each tablet contains:
- •Amlodipine – 5 mg
- •Telmisartan – 40 mg
- •Chlorthalidone – 6.25 mg
Indication: Treatment of essential hypertension inadequately controlled with dual-drug therapy.
Approval Date: November 2021
423 Mavacamten Capsules 2.5 mg / 5 mg / 10 mg / 15 mg
Composition: Each capsule contains:
- •Mavacamten – As labeled
Indication: Treatment of symptomatic obstructive Hypertrophic Cardiomyopathy (HCM) in adults.
Approval Date: December 2021
424 Pacritinib Capsules 100 mg
Composition: Each capsule contains:
- •Pacritinib – 100 mg
Indication: Treatment of intermediate or high-risk primary or secondary Myelofibrosis with severe thrombocytopenia.
Approval Date: December 2021
425 Amlodipine 5 mg + Indapamide SR 1.5 mg + Perindopril Arginine 5 mg Tablets
Composition: Each sustained-release tablet contains:
- •Amlodipine – 5 mg
- •Indapamide SR – 1.5 mg
- •Perindopril Arginine – 5 mg
Indication: Substitution therapy for management of essential hypertension in adults.
Approval Date: December 2021
426 Sodium Zirconium Cyclosilicate Powder for Oral Suspension 5 g / 10 g
Composition: Each sachet contains:
- •Sodium Zirconium Cyclosilicate – 5 g / 10 g
Indication: Treatment of Hyperkalemia in adult patients.
Approval Date: December 2021
427 Acalabrutinib Capsules 100 mg (Additional Indication)
Composition: Each capsule contains:
- •Acalabrutinib – 100 mg
Indication: First-line treatment of Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL).
Approval Date: December 2021
428 Olutasidenib Capsules 150 mg
Composition: Each capsule contains:
- •Olutasidenib – 150 mg
Indication: Treatment of relapsed or refractory Acute Myeloid Leukemia (AML) with IDH1 mutation.
Approval Date: December 2021
429 Vonoprazan Tablets 10 mg / 20 mg
Composition: Each film-coated tablet contains:
- •Vonoprazan Fumarate – 10 mg / 20 mg
Indication: Treatment of:
- •Gastroesophageal Reflux Disease (GERD)
- •Erosive Esophagitis
- •Helicobacter pylori eradication regimens
Approval Date: December 2021
430 Lutetium (177Lu) Vipivotide Tetraxetan Injection
Composition: Each vial contains:
- •Lutetium (177Lu) Vipivotide Tetraxetan – As labeled
Indication: Treatment of Prostate-Specific Membrane Antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
Approval Date: December 2021
431 Nirmatrelvir 150 mg + Ritonavir 100 mg Tablets (Co-Packaged)
Composition: Each treatment pack contains:
- •Nirmatrelvir Tablets – 150 mg
- •Ritonavir Tablets – 100 mg
Indication: Treatment of mild-to-moderate COVID-19 in adults at high risk for progression to severe disease.
Approval Date: December 2021
432 Mirikizumab Injection 300 mg/15 ml
Composition: Each vial contains:
- •Mirikizumab – 300 mg/15 ml
Indication: Treatment of moderately to severely active Ulcerative Colitis in adults.
Approval Date: January 2022
433 Amlodipine 5 mg + Indapamide SR 1.5 mg + Perindopril Arginine 10 mg Tablets
Composition: Each sustained-release tablet contains:
- •Amlodipine – 5 mg
- •Indapamide SR – 1.5 mg
- •Perindopril Arginine – 10 mg
Indication: Treatment of essential hypertension in adults.
Approval Date: January 2022
434 Deucravacitinib Tablets 6 mg
Composition: Each film-coated tablet contains:
- •Deucravacitinib – 6 mg
Indication: Treatment of moderate to severe Plaque Psoriasis in adults who are candidates for systemic therapy.
Approval Date: January 2022
435 Daridorexant Tablets 25 mg / 50 mg
Composition: Each film-coated tablet contains:
- •Daridorexant – 25 mg / 50 mg
Indication: Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
Approval Date: January 2022
436 Abemaciclib Tablets 50 mg / 100 mg / 150 mg / 200 mg (Additional Indication)
Composition: Each tablet contains:
- •Abemaciclib – 50 mg / 100 mg / 150 mg / 200 mg
Indication: Adjuvant treatment of HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence.
Approval Date: January 2022
437 Tirzepatide Injection 2.5 mg/0.5 ml, 5 mg/0.5 ml, 10 mg/0.5 ml, 15 mg/0.5 ml
Composition: Each prefilled pen contains:
- •Tirzepatide – As labeled
Indication: Improvement of glycemic control in adults with Type 2 Diabetes Mellitus.
Approval Date: February 2022
438 Ciltacabtagene Autoleucel Cell Suspension
Composition: Autologous genetically modified CAR-T cell therapy targeting BCMA.
Indication: Treatment of relapsed or refractory Multiple Myeloma after prior lines of therapy.
Approval Date: February 2022
439 Amlodipine 10 mg + Telmisartan 40 mg + Chlorthalidone 12.5 mg Tablets
Composition: Each tablet contains:
- •Amlodipine – 10 mg
- •Telmisartan – 40 mg
- •Chlorthalidone – 12.5 mg
Indication: Treatment of essential hypertension not adequately controlled with dual therapy.
Approval Date: February 2022
440 Lenacapavir Injection 463.5 mg/1.5 ml
Composition: Each vial contains:
- •Lenacapavir Sodium equivalent to Lenacapavir – 463.5 mg/1.5 ml
Indication: Treatment of multidrug-resistant HIV-1 infection in heavily treatment-experienced adults.
Approval Date: February 2022
441 Oteseconazole Capsules 150 mg
Composition: Each capsule contains:
- •Oteseconazole – 150 mg
Indication: Reduction in the incidence of recurrent Vulvovaginal Candidiasis (RVVC) in females with a history of recurrent infections.
Approval Date: February 2022
442 Amlodipine 10 mg + Telmisartan 40 mg + Chlorthalidone 6.25 mg Tablets
Composition: Each tablet contains:
- •Amlodipine – 10 mg
- •Telmisartan – 40 mg
- •Chlorthalidone – 6.25 mg
Indication: Treatment of essential hypertension not adequately controlled with dual therapy.
Approval Date: February 2022
443 Mavacamten Capsules 2.5 mg / 5 mg / 10 mg / 15 mg (Additional Approval)
Composition: Each capsule contains:
- •Mavacamten – As labeled
Indication: Treatment of symptomatic New York Heart Association (NYHA) Class II–III obstructive Hypertrophic Cardiomyopathy (HCM).
Approval Date: March 2022
444 Niraparib Tablets 100 mg
Composition: Each film-coated tablet contains:
- •Niraparib Tosylate Monohydrate equivalent to Niraparib – 100 mg
Indication: Maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Approval Date: March 2022
445 Amlodipine 5 mg + Telmisartan 80 mg + Chlorthalidone 12.5 mg Tablets
Composition: Each tablet contains:
- •Amlodipine – 5 mg
- •Telmisartan – 80 mg
- •Chlorthalidone – 12.5 mg
Indication: Treatment of essential hypertension in adults.
Approval Date: March 2022
446 Vonoprazan 20 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg Combipack
Composition: Each treatment kit contains:
- •Vonoprazan – 20 mg
- •Amoxicillin – 1000 mg
- •Clarithromycin – 500 mg
Indication: Eradication of Helicobacter pylori infection in adults.
Approval Date: March 2022
447 Olaparib Tablets 100 mg / 150 mg (Additional Indication)
Composition: Each film-coated tablet contains:
- •Olaparib – 100 mg / 150 mg
Indication: Adjuvant treatment of BRCA-mutated HER2-negative high-risk early breast cancer.
Approval Date: March 2022
448 Faricimab Injection 120 mg/ml
Composition: Each vial contains:
- •Faricimab-svoa – 120 mg/ml
Indication: Treatment of:
- •Neovascular (Wet) Age-Related Macular Degeneration (AMD)
- •Diabetic Macular Edema (DME)
Approval Date: February–March 2022
449 Amlodipine 10 mg + Telmisartan 80 mg + Chlorthalidone 12.5 mg Tablets
Composition: Each tablet contains:
- •Amlodipine – 10 mg
- •Telmisartan – 80 mg
- •Chlorthalidone – 12.5 mg
Indication: Treatment of essential hypertension not adequately controlled with combination therapy.
Approval Date: March 2022
450 Fedratinib Capsules 100 mg
Composition: Each capsule contains:
- •Fedratinib Hydrochloride equivalent to Fedratinib – 100 mg
Indication: Treatment of intermediate-2 or high-risk primary or secondary Myelofibrosis in adults.
Approval Date: March 2022
The increasing number of CDSCO drug approvals highlights the continuous advancement of pharmaceutical innovation in India. From novel therapies and additional strengths to fixed-dose combinations and new dosage forms, these approvals contribute significantly to improving patient care and expanding treatment accessibility across the country.
As regulatory requirements and healthcare needs continue to evolve, staying updated with the latest CDSCO-approved drugs becomes essential for pharmaceutical businesses, healthcare institutions, and medical professionals. Regular monitoring of approval trends can help organizations identify market opportunities, strengthen product portfolios, and make informed strategic decisions in India's dynamic