Regulatorische Updates

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

The FDA has approved ANDA078889 for generic metoprolol succinate extended‑release tablets (100 mg and 200 mg) from several manufacturers.

The FDA has approved ANDA 076251 submitted by Barr for fluoxetine hydrochloride oral capsules, 40 mg base, now listed as discontinued.

The FDA authorized Celcuity's small‑molecule inhibitor Revtorpyk (gedatolisib) for hormone‑receptor‑positive, HER2‑negative breast cancer without PIK3CA mutations, to be used with fulvestrant and optionally Ibrance.

The FDA approved IPCA Labs' ANDA090249 for a 500 mg oral chloroquine phosphate tablet in 2009; the product is currently listed as discontinued.

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.

Biogen and Eisai secured FDA approval for a subcutaneous injection formulation of Leqembi, enabling patients to start and maintain treatment without IV infusion.

The FDA approved ANDA 080036 for MK Labs' SOSOL oral tablet containing 500 mg sulfisoxazole. The product is listed as discontinued.

FDA has approved ANDA078641 for a prescription injectable famotidine 10 mg/mL product marketed by Mylan Institutional LLC.

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

The FDA approved ANDA084231 for a 500 mg methocarbamol tablet submitted by Puracap Pharm; the product is currently listed as discontinued.

The FDA approved ANDA083606 for an oral tablet of butabarital sodium (16.2 mg) submitted by Solvay; the product is listed as discontinued.