Regulatorische Updates

The FDA has approved ANDA 076942 for a prescription 2% ketoconazole shampoo, marketed by Cosette Pharmaceuticals. Submission history includes labeling updates through 2020.

The FDA has approved application ANDA205336 for a prescription diphenhydramine hydrochloride injectable (50 mg/mL) product marketed by Avet Lifesciences for IM and IV use.

FDA approves Sevelamer Carbonate oral suspension (ANDA207291), a prescription product available in 800 mg and 2.4 g packets, sponsored by Macleods Pharms.

FDA has approved ANDA207613, authorizing oral Midodrine Hydrochloride prescription tablets in 2.5 mg, 5 mg, and 10 mg strengths from Umasuto and Rising Pharma.

The FDA has approved application ANDA090935 for oral prescription Warfarin Sodium tablets ranging from 1 mg to 10 mg, manufactured by Exelan Pharmaceuticals.

The FDA has approved the prescription transdermal patch TRANSDERM SCOP, containing 1 mg scopolamine per 72 hr, under NDA 017874. Baxter Healthcare is the manufacturer.

The FDA has granted approval for ANDA077248, an oral tablet formulation of pilocarpine hydrochloride (5 mg and 7.5 mg) manufactured by Impax Labs and Amneal Pharmaceuticals.

FDA granted approval for Watson Labs' ciprofloxacin hydrochloride ophthalmic solution (ANDA 076673), a prescription eye drop approved in 2005 with a labeling update in 2007.

FDA approved ANDA084113 for chlorpromazine hydrochloride 50 mg oral tablets, manufactured by Upsher‑Smith Laboratories, LLC.

The FDA has approved ANDA078948 for a prescription oral tablet of Ibandronate Sodium 150 mg, sponsored by Apotex and manufactured by Golden State Medical Supply.

FDA has approved application ANDA078052 for fosphenytoin sodium injection, a prescription product by Fresenius Kabi USA for IM and IV use.

The FDA has granted approval for Fresenius Kabi USA’s preservative‑free OCTREOTIDE acetate injectable products under ANDA 077457, covering three dosage strengths for injection.