法规动态

CARACO's ANDA078219 for oral escitalopram oxalate tablets (5 mg, 10 mg, 20 mg) has been granted tentative approval by the FDA.

FDA approved Lupin's ANDA209272 for metoprolol succinate extended‑release tablets in four strengths, all currently listed as discontinued.

The FDA’s database lists ANDA 077944 for meloxicam tablets (7.5 mg and 15 mg) by Lupin Pharmaceuticals, with several labeling submissions approved; the products are currently marked discontinued.

The FDA has approved application ANDA079162 for generic topiramate oral tablets (25 mg, 50 mg, 100 mg, 200 mg) manufactured by Cipla USA Inc. and Exelan Pharmaceuticals.

The government reiterated that the 1 trillion won additional funding for health‑insurance fee‑structure reform will not draw on savings from generic drug price cuts, but from reserves, premiums and treasury support.

FDA listed approval for ANDA078132 submitted by Northstar Healthcare covering oral ibuprofen tablets (400 mg, 600 mg, 800 mg) now marked discontinued.

The FDA approved ANDA080126 on Jan 21 1972 for Everylife's STANOZIDE oral tablets containing 100 mg and 300 mg of isoniazid, both now listed as discontinued.

The FDA granted approval for ANDA076620 on Oct 15, 2004, covering three oral fosinopril sodium tablet strengths submitted by Actavis Labs, all currently listed as discontinued.

The FTC says Aurobindo must sell four drugs to address antitrust concerns before finalizing its $250 million acquisition of Lannett.