Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants Tentative Approval for Dapagliflozin Tablets (ANDA219408)
Sciegen Pharmaceuticals received tentative FDA approval for 5 mg and 10 mg dapagliflozin tablets under ANDA219408.
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Regulatory Updates
Sep 17, 2026•1 min read
FDA NDA012126: 3M's ULO Oral Syrup Discontinued
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.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA201251 for Vancomycin Hydrochloride Injection
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.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA087564 for Isosorbide Dinitrate Tablet
The FDA approved application ANDA087564 for Sun Pharm Industries' oral tablet Isosorbide Dinitrate 30 mg, listed with a discontinued marketing status.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA 076235 for Carboplatin Injection (Fresenius Kabi USA)
The FDA approved ANDA 076235 for carboplatin injectable products submitted by Fresenius Kabi USA on Oct 14, 2004. All listed strengths are currently discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Teva's Chlordiazepoxide Hydrochloride Generic (ANDA 084769)
The FDA has approved Teva Pharmaceuticals' generic chlordiazepoxide hydrochloride oral capsules (ANDA 084769) with 25 mg strength and multiple NDC codes.
Regulatory Updates
Sep 14, 2026•1 min read
Oncogenic Therapeutics launches Phase 3 trial of Zaqibo (Jastafrazan) for H. pylori eradication
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.
Regulatory Updates
Sep 14, 2026•1 min read
South Korea's MFDS Joins ICMRA Executive Committee, First Time Representation
The MFDS has been elected to the ICMRA Executive Committee for 2026‑2029, marking its first seat on the global drug‑regulation decision body.
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Regulatory Updates
Sep 13, 2026•1 min read
MFDS launches new review system to cut new drug approval time to 240 days
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.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA077545 for Ondansetron Hydrochloride Tablets
FDA approved application ANDA077545 from Hikma International Pharmaceuticals for discontinued oral ondansetron tablets (4 mg, 8 mg, 24 mg) with multiple labeling supplements approved.
Regulatory Updates
Sep 12, 2026•1 min read
Laurus Labs Ltd Submits New Combination NDA 213696 to FDA
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.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Labeling Updates for Generic Levofloxacin Tablets (ANDA 076361)
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.