Alembic Pharmaceuticals Limited declared on Monday that five of its medications have been approved by the US Food & Drug Administration (USFDA).
A press release states that from April 1st, 2024, to May 8th, 2024, the company received five product approvals—three final and two tentative. This contains Clindamycin Phosphate Topical Gel USP 1%, Tretinoin Cream USP, 0.1%, Binimetinib, Single-Dose Prefilled Syringe, 1,000 mcg and 1,200 mcg of Selexipag Tablets, and Diazepam Injection USP, 10 mg/2 mL (5 mg/mL).
With the final clearance of Hoffmann LA Roche Inc. under the brand name Valium (Diazepam) Injection, Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringe is approved for the management of anxiety disorders or for the temporary relief of anxiety symptoms.
Actelion Pharmaceuticals Inc.’s provisional approval of Selexipag Tablets, 1,000 mcg and 1,200 mcg, under the brand name Uptravi, is intended to treat pulmonary arterial hypertension (PAH, WHO Group I) by delaying the progression of the illness and lowering the risk of hospitalization.
Binimetinib, a kinase inhibitor with preliminary approval from Array Biopharm under the trade name Mektovi, is recommended for use in conjunction with encorafenib to treat patients with metastatic or unresectable melanoma that has a BRAF V600E or V600K mutation.
For the topical treatment of acne vulgaris, Bausch Health US, LLC., USA’s Tretinoin Cream USP, 0.1%, final approval—marketed under the trade name Retin-A—is recommended.
With Pharmacia & Upjohn’s final approval, Clindamycin Phosphate Topical Gel USP 1%, marketed under the brand name Cleocin T, is authorized for the treatment of acne vulgaris. Alembic has received 201 ANDA approvals in total from the USFDA (173 final approvals and 28 tentative approvals).