規制動向

The FDA has listed the Lactulose oral and rectal solution (product #001) as discontinued under NDA017906, sponsored by Solvay.

FDA records show Warner Chilcott's Duraquin oral extended‑release tablet (quinine gluconate 330 mg) is discontinued under application NDA017917.

The FDA has granted approval for several supplemental submissions related to LIDOPEN, an injectable lidocaine product now 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 approved TAZVERIK, a prescription oral tablet for EPIZYME Inc., under NDA 213400 with priority review and orphan designation.

The FDA has granted approval (NDA012283) for Sanofi Aventis’s HYGROTON oral tablets containing chlorthalidone 25 mg and 50 mg, previously listed as discontinued but not withdrawn for safety reasons.

The FDA records show that 3M's oral syrup product ULO, containing 25 mg/5 mL chlophedianol hydrochloride, is listed as discontinued under application NDA012126.

The FDA approved NDA011960 for ARISTOCORT oral syrup, a 2 mg/5 mL Triamcinolone Acetate product by Astellas, now listed as discontinued.

The FDA record NDA050306 lists five GEOPEN injectable carbenicillin products, all marked discontinued.

The FDA granted approval for NDA 017830, authorizing the prescription oral tablet Lodosyn (carbidopa) from Bausch Health US and Oceanside Pharmaceuticals.

The FDA granted approval (NDA017421) for DIAL’s discontinued topical solution containing 0.25% hexachlorophene.

The FDA has listed NDA 214937 for a prescription helium inhalation gas (HELIUM, USP) submitted by Westair Gases & Equipment Inc., with submission documents dated June‑July 2020.