規制動向

The MHRA identified signal crossover, erroneous traces and dropouts in wireless cardiotocography systems that use radio‑frequency telemetry.

The FDA has granted approval for ANDA077824, authorizing Amneal Pharmaceuticals’ oral ranitidine tablets in 150 mg and 300 mg strengths, now listed as discontinued.

Martindale Pharmaceuticals reported a linear barcode error affecting certain batches of Clobazam 5 mg/5 mL and 10 mg/5 mL oral suspension (150 mL) to the MHRA.

The FDA has approved an oral suspension of griseofulvin (125 mg/5 mL) from Actavis Pharma under ANDA 065394.

The FDA approved Strides Pharma's minocycline hydrochloride oral tablets (50 mg, 75 mg, 100 mg) under ANDA 065131, confirming prescription status.

The FDA’s ANDA070169 filing for Tolazamide 500 mg oral tablets by USL Pharma is marked as discontinued.

The FDA approved ANDA063264 for Amikacin Sulfate injectable by Hospira. The product is listed as discontinued and includes multiple labeling and manufacturing supplemental submissions.

The FDA has granted approval (NDA012283) for Sanofi Aventis’s HYGROTON oral tablets containing chlorthalidone 25 mg and 50 mg, previously listed as discontinued but not withdrawn for safety reasons.

The ministry says health platforms should not be judged by general industry standards and need specific preventive regulation, especially after the recent pharmacy act amendment.

The Ministry of Food and Drug Safety disclosed that Kyungbang Shinyak received seven GMP observations in facility equipment and manufacturing, all categorized as "Other" with no major issues.

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.

The FDA approved HIKMA's ANDA062720 for cephapirin sodium injectable products, all listed as discontinued, with approval dated July 2, 1987.