USFDA3 Jul 2024, 06:30 pm
Alembic Pharmaceuticals Secures 11 US FDA Product Approvals in Q2 2024
AI Summary
Alembic Pharmaceuticals has announced that it received 11 US Food and Drug Administration (USFDA) product approvals (Final & Tentative) during the quarter ended 30th June, 2024. This brings the company's cumulative total of Anda approvals from USFDA to 206 (179 final approvals and 27 tentative approvals). The approved products include Clindamycin Phosphate Topical Gel USP 1%, Diazepam Injection USP, 10mg/2mL (5 mg/mL), Single-Dose Prefilled Syringe, Selexipag, Binimetinib Tablets, Tretinoin Cream USP, 0.1%, and Sacubitril and Valsartan Tablets.
Key Highlights
- Alembic Pharmaceuticals received 11 US FDA product approvals in Q2 2024.
- This brings the company's total Anda approvals from USFDA to 206.
- The approved products include Clindamycin Phosphate Topical Gel USP 1%, Diazepam Injection USP, 10mg/2mL (5 mg/mL), Single-Dose Prefilled Syringe, Selexipag, Binimetinib Tablets, Tretinoin Cream USP, 0.1%, and Sacubitril and Valsartan Tablets.
- The company has a cumulative total of 179 final approvals and 27 tentative approvals from USFDA.
- The approved products are for various indications including acne vulgaris, anxiety disorders, pulmonary arterial hypertension, melanoma, and heart failure.