規制動向

The FDA approved ANDA077302 for Actavis Pharma’s oral extended‑release capsules containing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate in multiple strengths.

The FDA has granted approval for ANDA077060, authorizing the prescription extended‑release metformin hydrochloride tablet (500 mg) marketed by Zydus Lifesciences.

The FDA has approved ANDA211623 for carbamazepine extended‑release tablets (100 mg, 200 mg, 400 mg) submitted by Unique Pharm, with labeling cleared in Jan 2024.

The FDA approved ANDA076667 for an over‑the‑counter extended‑release oral tablet containing 60 mg fexofenadine HCl and 120 mg pseudoephedrine HCl, marketed by Dr. Reddy’s.

The FDA approved ANDA077968 on May 24, 2007 for IMPAX Labs' oral extended‑release alprazolam tablets, all listed as discontinued products.

The FDA approved ANDA 076368 for two extended‑release potassium chloride tablets (10 mEq and 20 mEq) marketed by AdaRe Pharm and manufactured by Sun Pharmaceutical.

The FDA has approved AUVELITY, an oral extended‑release tablet combining bupropion hydrochloride and dextromethorphan hydrobromide under NDA 215430.

The FDA has approved ANDA212645 for paroxetine extended‑release tablets (12.5 mg, 25 mg, 37.5 mg) marketed by Cadila Pharm Ltd and Modavar Pharmaceuticals.

FDA has approved ANDA202711 for Zydus Pharms' prescription indomethacin 75 mg extended‑release oral capsule, with labeling supplements filed in 2017, 2019, 2021 and 2024.

FDA approved multiple oral extended‑release tablet products of pramipexole dihydrochloride under ANDA202353, covering five strengths and several labeling supplements.

The FDA approved ANDA 078873 for Teva’s methylphenidate hydrochloride extended‑release capsules (40 mg, 50 mg, 60 mg). All listed products are currently discontinued.

The FDA has approved the ANDA077078 application for metformin hydrochloride 750 mg extended‑release tablets marketed by Zydus Lifesciences.