規制動向

The FDA granted approval for ANDA 084469, covering a 50 mg oral tablet of hydralazine hydrochloride submitted by IVAX Sub Teva Pharm. The product is listed as discontinued.

The FDA has approved ANDA078203 for Lorazepam tablets (0.5 mg, 1 mg, 2 mg) manufactured by Leading Pharma, LLC.

The FDA has approved Bausch & Lomb’s ophthalmic diclofenac sodium 0.1% solution (ANDA078792) for prescription use, confirming its safety and efficacy.

FDA granted approval for ANDA079186, a generic Dorzolamide Hydrochloride ophthalmic solution submitted by AM Regent, with original approval in 2009 and a labeling supplement in 2020.

The FDA approved the abbreviated new drug application ANDA079164 for Flecainide Acetate tablets (50 mg, 100 mg, 150 mg) from Chartwell RX, though the products are currently listed as discontinued.

The FDA has granted labeling approval for Glenmark Pharmaceuticals’ generic carvedilol tablets (ANDA078251), available in 3.125 mg, 6.25 mg, 12.5 mg and 25 mg oral dosage forms.

FDA has approved Chartwell RX's generic allopurinol tablets (100 mg and 300 mg) under ANDA 077353, confirming prescription status and labeling updates.

The FDA has approved application ANDA078979 for the oral delayed‑release capsule of DIVALPROEX SODIUM, manufactured by NorthStar Rx LLC and Dr. Reddy's Laboratories Ltd.

The FDA has approved a series of manufacturing (CMC) and labeling submissions for the discontinued oral chlorthalidone 25 mg tablet (product 001, ANDA 087292).

The FDA has approved Alembic Pharmaceuticals’ generic Nitrofurantoin capsules (ANDA211935) for oral prescription use in 25 mg, 50 mg, and 100 mg strengths.

The FDA has approved Torrent Pharmaceuticals' generic esomeprazole magnesium delayed‑release oral suspension (ANDA212652), a prescription oral drug with 10 mg base per packet.

The FDA approved ANDA080279 for a 5 mg oral prednisone tablet submitted by Inwood Labs; the product is listed as discontinued.