規制動向

The FDA granted approval for ANDA 084469, covering a 50 mg oral tablet of hydralazine hydrochloride submitted by IVAX Sub Teva Pharm. The product is listed as discontinued.

The FDA has approved ANDA087463 for the oral tablet Oxycet, containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen, manufactured by SpecGx LLC.

The FDA has approved application ANDA077013 for pravastatin sodium tablets (10‑80 mg) from sponsor Pharmobedient; all listed product numbers are marked discontinued.

The FDA has approved ANDA 087562 submitted by IDT Australia Ltd for a 50 mg oral tablet of dipyridamole, originally listed as discontinued.

The FDA granted approval (ANDA 084031) for BARR's sulfisozole 500 mg oral tablet, which is listed as discontinued. A labeling supplement was filed in 1995.

Sun Pharm Industries' quinidine sulfate tablet (200 mg) received FDA approval under ANDA081030, with manufacturing and labeling submissions approved between 1989 and 2010. The product is currently listed as discontinued.

FDA approved Sun Pharm Industries Ltd's ANDA 076332 for Fluconazole oral suspension (200 mg/5 mL and 50 mg/5 mL). Both products are now discontinued.

FDA has approved ANDA213409 for two oral solution products of nimodipine from ALKEM Labs, with one product receiving prescription status and the other tentative approval.

The FDA approved application ANDA091667 for oral MISOPROSTOL tablets (0.1 mg and 0.2 mg) from Novel Labs, though both products are listed as discontinued.

FDA has approved an ANDA for a 1 mg oral folic acid tablet submitted by PurePac Pharm; the product is listed as discontinued.

FDA granted approval (ANDA076850) for Fougera Pharms' terconazole 80 mg vaginal suppository, now listed as discontinued.

The Korean MFDS announced a meeting on Oct 10 to guide herbal medicine makers on the new standard decoction definition effective Sep 2024 and share change‑approval procedures.