규제 업데이트

The FDA has granted approval for Alembic’s prescription tretinoin 0.05% cream, submitted under ANDA214590.

Cipla has an ANDA (application number ANDA077221) for lamivudine tablets in 150 mg and 300 mg strengths, with standard labeling submissions approved in 2019.

The FDA has approved Mylan Pharmaceuticals' generic levetiracetam tablets (250 mg, 500 mg, 750 mg) under ANDA 076919.

FDA approved ANDA076367 for a 0.1% amcinonide prescription ointment; the product is currently listed as discontinued.

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.

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.

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.

The FDA granted approval for ANDA 076648, covering nitrofurantoin (75 mg + 25 mg macrocrystalline) oral capsules marketed by Chartwell Rx.

FDA granted approval for ANDA078414, authorizing Oxford Pharmaceuticals' generic amlodipine besylate tablets in 2.5 mg, 5 mg, and 10 mg strengths.

The FDA approved ANDA 078126 for fosphenytoin sodium injectable in August 2007, issued multiple labeling supplements through 2022, and the product is currently discontinued.

Philips Ingenia Achieva and Intera MR scanners export DTI scans with incorrect diffusion directions when using Enhanced MR DICOM, preventing proper tractography processing.

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.