Regulatorische Updates

On September 14, 2026, the Ministry of Health and Welfare announced the appointment of Lee Su-wan to the position of Section Chief in the Disability Independence Division.

The FDA has approved labeling for Chartwell RX's fluticasone propionate nasal spray (ANDA078492), a prescription nasal spray.

The FDA has approved ANDA 076504 for a prescription fluticasone propionate nasal spray, manufactured by Hikma Pharmaceuticals and Golden State Medical Supply.

Mallinckrodt Inc. received FDA approval for its original Abbreviated New Drug Application (ANDA) 078273 on September 19, 2007.

The FDA has approved several manufacturing (CMC) supplement submissions for Sandoz’s Orphenadrine Citrate extended‑release tablet (ANDA 085046), which is currently listed as discontinued.

The FDA approved ANDA089615 for ISOETHARINE HYDROCHLORIDE inhalation solution (0.125%) by AstraZeneca. The product is listed as discontinued.

The FDA approved the abbreviated new drug application ANDA079164 for Flecainide Acetate tablets (50 mg, 100 mg, 150 mg) from Chartwell RX, though the products are currently listed as discontinued.

The FDA has approved ANDA077947 submitted by Baxter Healthcare Corp for two discontinued Fluconazole injectable products in 0.9% sodium chloride, strengths 200 mg/100 mL and 400 mg/200 mL.

The FDA record for NDA018025 shows the injectable form of furosemide marked as discontinued after a series of approved labeling and manufacturing supplemental submissions.

Ethicon recalls PERMA‑HAND™ Silk Suture after discovering an alcohol‑based tubing fluid was used in manufacturing.

The FDA approved ANDA080713 for Watson Labs' oral tablet TripeLennaMine Hydrochloride 50 mg, now listed as discontinued, with a history of multiple supplemental approvals.

The FDA’s ANDA 077179 approval covers oral capsule products of amlodipine besylate combined with benazepril hydrochloride, all listed as discontinued, with labeling submissions approved in 2011 and 2016.