Regulatory Updates

Scilex Pharmaceuticals' GLOPERBA, an oral colchicine solution (0.6 mg/5 mL), received FDA approval under NDA 210942, with supplemental updates in 2021 and 2024.

The FDA's recent ANDA 210602 approval includes a range of ibuprofen oral suspension products, covering dye‑free, kosher, and flavored versions for OTC use.

The FDA has approved ANDA210245 submitted by MSN for generic pomalidomide capsules in 2 mg, 3 mg, and 4 mg strengths.

The FDA has approved ANDA209591 for a prescription oral tablet combining amlodipine besylate and olmesartan medoxomil, sponsored by Hetero Labs.

The FDA approved ANDA209242 for Camber’s prescription oral tablet combining olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide in multiple strengths.

The FDA has approved application ANDA208867 for 50 mg oral tablets of propylthiouracil, manufactured by Macleods Pharmaceuticals. The labeling submission was approved on June 26 2024.

The FDA has approved the prescription inhalation product NITROGEN, NF (NDA212315), a medical gas for respiratory use, sponsored by Universal Industrial Gases, Inc.

The FDA granted approval for artesunate 110 mg/vial for intravenous use under NDA 213036, an orphan-designated new molecular entity, with labeling updates through 2025.

The FDA approved application ANDA091667 for oral MISOPROSTOL tablets (0.1 mg and 0.2 mg) from Novel Labs, though both products are listed as discontinued.

The FDA has approved Chartwell Rx's ANDA091340 for the ophthalmic solution TRAVOPROST (0.004%) as a prescription product.

The FDA approved ANDA083784 for a 12.5 mg oral Meclizine Hydrochloride tablet submitted by IVAX Sub Teva Pharm; the product is currently listed as discontinued.

FDA has approved an ANDA for a 1 mg oral folic acid tablet submitted by PurePac Pharm; the product is listed as discontinued.