Regulatorische Updates

The FDA granted approval for ANDA 076886, a fosphenytoin sodium injection by DR REDDYS, now listed as discontinued. Original approval in 2007 with labeling updates in 2020.

The FDA approved application ANDA076605 for Ranbaxy’s oral gabapentin tablets (600 mg and 800 mg). Both products are currently listed as discontinued.

The FDA has approved ANDA217961 for CARBIDOPA 25 mg oral tablets, a prescription product submitted by Regcon Holdings.

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 ANDA079044 for a nicotine polacrilex chewing gum marketed as an over‑the‑counter product, with multiple manufacturers listed.

The FDA has approved ANDA 084872 for a 25 mg oral tablet of Meclizine Hydrochloride marketed by BUNDY, with a discontinued marketing status.

The FDA has granted approval for several supplemental submissions related to LIDOPEN, an injectable lidocaine product now discontinued.

The FDA has approved ANDA080630 for a 25 mg oral tablet of cortisone acetate, submitted by IVAX Sub Teva Pharm, with approval dated Jan 3 1972.

FDA granted approval (status AP) for VANGARD's ANDA088010 covering a 10 mg oral capsule of chlordiazepoxide hydrochloride, listed as discontinued.

The FDA has approved two prescription oral tablets combining irbesartan and hydrochlorothiazide under ANDA 077446, with multiple labeling supplements approved.

The FDA has approved ANDA 077139 for Teva Pharm USA’s carboplatin injectable products, with multiple supplemental approvals covering labeling and manufacturing.

MFDS announced partial amendments to drug approval regulations, reducing documentation for medical high‑pressure gases and widening multiple‑specification allowances for orphan‑drug active ingredients.