法规动态

The Korean MFDS announced ten health‑functional food ingredients, such as bilberry extract, will undergo a regular re‑assessment in 2027.

The FDA approved Sandoz's ANDA084617 for the oral tablet DRALSERP containing hydralazine hydrochloride 25 mg and reserpine 0.1 mg; the product is listed as discontinued.

FDA approved ANDA084113 for chlorpromazine hydrochloride 50 mg oral tablets, manufactured by Upsher‑Smith Laboratories, LLC.

FDA has approved multiple manufacturing (CMC) and labeling submissions for the oral 65 mg Propoxyphe ne Hydrochloride capsule, now listed as discontinued.

The FDA approved ANDA081142 for an aminophylline injectable product (25 mg/mL) submitted by Teva Parenteral, with original and supplemental approvals in 1991 and 1995.

FDA has approved NDA007392 for Seconal Sodium injectable, a secobarbital sodium product by Lilly, with a detailed submission history and discontinued marketing status.

FDA has approved ANDA078292 submitted by Rhodes for oral dronabinol capsules in 10 mg, 5 mg, and 2.5 mg strengths; all products are listed as discontinued.

FDA approved an ANDA (ANDA080517) for Watson Labs' Prednisolone Sodium Phosphate injectable, originally submitted in 1974; the product is now listed as discontinued.

The FDA granted approval for Baxter Healthcare's prescription Sorbitol 3% irrigation solution (NDA017863), a human drug administered via irrigation.

Domestic manufacturers have issued voluntary recalls for certain batches of diabetes treatments and anti‑emetic tablets after detecting contamination, potency failures and impurity exceedances.

Gyeonggi regional pharmacy chairs reject the government’s plan to broaden home delivery of medicines and OTC items, citing conflict with the Constitutional Court ruling.

The FDA has approved ANDA078889 for generic metoprolol succinate extended‑release tablets (100 mg and 200 mg) from several manufacturers.