Latest news and insights on the pharmaceutical industry | Indian Pharma Post
Drug Approval
Drug Approval | 20 March 2025

USFDA grants Priority Review for new indication of finerenone for patients with common heart failure

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure

Drug Approval
Drug Approval | 19 March 2025

Zydus receives final approval from USFDA for Apalutamide Tablets, 60 mg

Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer

Drug Approval
Drug Approval | 19 March 2025

Briefs: Zydus, Alkem Laboratories, Alkem Medtech and Relonchem

Alkem Medtech to acquire 100% stake of Bombay Ortho

Drug Approval
Drug Approval | 19 March 2025

RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation

Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes

Drug Approval
Drug Approval | 18 March 2025

Lupin receives tentative approval from USFDA for Amifampridine Tablets

Amifampridine Tablets, 10 mg are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older.

Drug Approval
Drug Approval | 17 March 2025

Zydus receives final approval from USFDA for Eluxadoline Tablets, 75 mg and 100 mg

Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea

Drug Approval
Drug Approval | 13 March 2025

Zydus receives final approval from USFDA for Methenamine Hippurate Tablets USP, 1 gram

Methenamine Hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections

Drug Approval
Drug Approval | 10 March 2025

Zydus receives final approval from USFDA for Ketoconazole Shampoo, 2%

Ketoconazole shampoo is an antifungal medication used to treat dandruff

Drug Approval
Drug Approval | 07 March 2025

Briefs: Alembic Pharma and IOL Chemicals and Pharmaceuticals

USFDA inspection at Alembic Pharma's Bioequivalence facility

Drug Approval
Drug Approval | 07 March 2025

Lupin Launches Rivaroxaban Tablets USP, 2.5mg in US

Rivaroxaban Tablets USP, 2.5 mg, is bioequivalent to Xarelto® Tablets, 2.5 mg of Janssen Pharmaceuticals

Drug Approval
Drug Approval | 06 March 2025

Zydus receives final approval from USFDA for Dasatinib Tablets

Dasatinib is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase

Drug Approval
Drug Approval | 05 March 2025

Unichem Laboratories receives 4 observations from USFDA for Pithampur API facility

The company will provide the necessary response on these observations to USFDA within stipulated 15 days

Drug Approval
Drug Approval | 04 March 2025

Venus Remedies secures firstiInternational market authorization for Sugammadex from the Philippines

The approval marks Venus Remedies’ strategic entry into complex generics, expanding its injectable portfolio beyond traditional formulations

Drug Approval
Drug Approval | 27 February 2025

USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit

The observations issued are neither repeated observations nor related to data integrity

Drug Approval
Drug Approval | 27 February 2025

Briefs: Emcure and Relonchem

USFDA inspection at Emcure Pharmaceuticals API facility

Drug Approval
Drug Approval | 27 February 2025

Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure

Drug Approval
Drug Approval | 23 February 2025

Briefs: Syngene International and Cipla

Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’

Drug Approval
Drug Approval | 22 February 2025

Zydus receives final approval from USFDA for Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg

Ibuprofen and famotidine combination is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis

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