規制動向

The FDA has approved a series of supplemental labeling and manufacturing submissions for the discontinued oral tablet Phentermine Hydrochloride (37.5 mg) under ANDA 088596.

FDA has approved labeling submissions for ANDA077672 covering stavudine oral capsules from Aurobindo Pharma; all listed products are marked discontinued.

The FDA has granted approval for an over‑the‑counter famotidine tablet (10 mg and 20 mg) under ANDA 077367, sponsored by Dr. Reddy’s Laboratories Ltd.

Analysis of NHIS data shows that in 2023, 38 of 60 Korean medical districts (63.3%) had pediatric inpatient self‑sufficiency rates below the national average of 79%.

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

The FDA record shows UTICORT lotion, a 0.025% betamethasone benzoate topical product by Parke‑Davis, is listed as discontinued.

The FDA’s NDA006920 for Lederle’s oral drug Triple Sulfas includes two discontinued formulations—a suspension and a tablet—both containing trisulfapyrimidines, sulfamerazine, and sulfamethazine.

The FDA database shows multiple oral tablet products of Fexofenadine Hydrochloride under application ANDA076502, with strengths from 30 mg to 180 mg, some discontinued and others OTC.

The FDA approved Sandoz's ANDA 076231 for a 0.3% OFLOXACIN ophthalmic solution, though the product is listed as discontinued.

The FDA has approved the ANDA for gemcitabine injection (ANDA079183) from Hospira, Inc., with details on submission history and labeling updates.

The FDA has approved Apotex’s generic Tizanidine Hydrochloride oral capsules (2 mg, 4 mg, 6 mg) under application ANDA078868.

FDA has approved labeling supplements for ANDA078564, a discontinued Granisetron Hydrochloride injection product by Wockhardt USA, with submissions dated 2008, 2014, and 2015.