Alembic Pharmaceuticals Receives 5 USFDA Product Approvals in Q1FY25

Receives 3 final and 2 tentative product approvals thus far in Q1FY25

09 May 2024, Bengaluru: Alembic Pharmaceuticals Limited (Alembic) announced today that it has received US Food & Drug Administration (USFDA) approvals on five of its products. The company has received five product approvals – three final and two tentative – from 1^st April 2024 till 8^th May 2024. This includes Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringe, Selexipag Tablets 1,000 mcg and 1,200 mcg, Binimetinib, Tretinoin Cream USP, 0.1%, and Clindamycin Phosphate Topical Gel USP 1%.

Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringe, final approval, of Hoffmann LA Roche Inc with brand name, Valium® (Diazepam) Injection, is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.

Selexipag Tablets 1,000 mcg and 1,200 mcg, tentative approval, of Actelion Pharmaceuticals Inc. with brand name, Uptravi, is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalisation for PAH.

Binimetinib, tentative approval, of Array Biopharm with brand name, Mektovi, is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.

Tretinoin Cream USP, 0.1%, final approval, of Bausch Health US, LLC., USA with brand name, Retin-A, is indicated for topical application in the treatment of acne vulgaris.

Clindamycin Phosphate Topical Gel USP 1%, final approval, of Pharmacia & Upjohn with brand name, Cleocin T, is indicated in the treatment of acne vulgaris.

Alembic has a cumulative total of 201 ANDA approvals (173 final approvals and 28 tentative approvals) from USFDA.