규제 업데이트

Sciegen Pharmaceuticals received tentative FDA approval for 5 mg and 10 mg dapagliflozin tablets under ANDA219408.

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.

FDA approved ANDA201251 submitted by Teva Pharm USA for two vancomycin hydrochloride injectable products (500 mg and 1 g per vial), both listed as discontinued.

The FDA approved application ANDA087564 for Sun Pharm Industries' oral tablet Isosorbide Dinitrate 30 mg, listed with a discontinued marketing status.

The FDA approved ANDA 076235 for carboplatin injectable products submitted by Fresenius Kabi USA on Oct 14, 2004. All listed strengths are currently discontinued.

The FDA has approved Teva Pharmaceuticals' generic chlordiazepoxide hydrochloride oral capsules (ANDA 084769) with 25 mg strength and multiple NDC codes.

Oncogenic Therapeutics secured MFDS approval for a Phase 3 study of its P‑CAB drug Zaqibo to treat Helicobacter pylori infection in 414 patients across 24 Korean sites.

The MFDS has been elected to the ICMRA Executive Committee for 2026‑2029, marking its first seat on the global drug‑regulation decision body.

South Korea's MFDS will activate a parallel-review process within a month, assigning multiple reviewers per area to reduce new drug approval timelines to 240 days.

FDA approved application ANDA077545 from Hikma International Pharmaceuticals for discontinued oral ondansetron tablets (4 mg, 8 mg, 24 mg) with multiple labeling supplements approved.

Laurus Labs Ltd filed a Type 4 New Combination NDA (213696) with the FDA, recorded as a standard priority original submission on Jan 25 2022.

The FDA has approved a series of labeling submissions for generic levofloxacin tablets (250 mg, 500 mg, 750 mg) under ANDA 076361, most recently on Sep 9 2024.