Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Alembic’s Tretinoin 0.05% Topical Cream (ANDA214590)
The FDA has granted approval for Alembic’s prescription tretinoin 0.05% cream, submitted under ANDA214590.
Regulatory Updates
Sep 17, 2026•1 min read
Cipla Submits ANDA077221 for Lamivudine Tablets (150 mg & 300 mg)
Cipla has an ANDA (application number ANDA077221) for lamivudine tablets in 150 mg and 300 mg strengths, with standard labeling submissions approved in 2019.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Mylan Generic Levetiracetam Tablets (ANDA 076919)
The FDA has approved Mylan Pharmaceuticals' generic levetiracetam tablets (250 mg, 500 mg, 750 mg) under ANDA 076919.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA076367 for Amcinonide Topical Ointment
FDA approved ANDA076367 for a 0.1% amcinonide prescription ointment; the product is currently listed as discontinued.
Regulatory Updates
Sep 17, 2026•1 min read
Trinity Biotech Recalls Oxalate Reagent B (Lot 2500711) Due to Performance Variability
Trinity Biotech is recalling Oxalate Reagent B (Product Code 591-2, Lot 2500711) because of performance variability causing negative bias and under‑recovery of oxalate values, potentially yielding falsely low patient results.
Regulatory Updates
Sep 17, 2026•1 min read
Trinity Biotech Recalls Oxalate Reagent B Lot 2500711 – Health Canada
Trinity Biotech is recalling Oxalate Reagent B (Product Code 591-2, Lot 2500711) due to performance variability that may produce falsely low oxalate results. Users should stop use and quarantine inventory.
Regulatory Updates
Sep 17, 2026•1 min read
Chelsea midfielder Mihailo Mudric’s Meldonium ban lifted after four-year suspension
Chelsea FC’s Mihailo Mudric, previously banned for four years after testing positive for the prohibited metabolic modulator Meldonium, has had his sanction lifted and is set to return.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA 076648 for Nitrofurantoin Oral Capsules (Monohydrate/Macrocrystals)
The FDA granted approval for ANDA 076648, covering nitrofurantoin (75 mg + 25 mg macrocrystalline) oral capsules marketed by Chartwell Rx.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Oxford Generic Amlodipine Besylate Tablets (ANDA078414)
FDA granted approval for ANDA078414, authorizing Oxford Pharmaceuticals' generic amlodipine besylate tablets in 2.5 mg, 5 mg, and 10 mg strengths.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA 078126 for Fosphenytoin Sodium Injection (Now Discontinued)
The FDA approved ANDA 078126 for fosphenytoin sodium injectable in August 2007, issued multiple labeling supplements through 2022, and the product is currently discontinued.
Regulatory Updates
Sep 17, 2026•1 min read
Philips MR Systems Export Incorrect Diffusion Data in Enhanced DICOM Format
Philips Ingenia Achieva and Intera MR scanners export DTI scans with incorrect diffusion directions when using Enhanced MR DICOM, preventing proper tractography processing.
Regulatory Updates
Sep 17, 2026•1 min read
Eun-gyosan OTC Drug Listed for Cold‑Related Sore Throat, Thirst, Cough and Headache in Korea
A pharmacist’s case note highlights that Korea’s Eun-gyosan OTC product is officially indicated for throat pain, thirst, cough and headache accompanying the common cold.