Regulatorische Updates

The FDA has approved ANDA077947 submitted by Baxter Healthcare Corp for two discontinued Fluconazole injectable products in 0.9% sodium chloride, strengths 200 mg/100 mL and 400 mg/200 mL.

The FDA’s ANDA077657 for lorazepam tablets (0.5 mg, 1 mg, 2 mg) lists all products as discontinued and details several supplemental labeling submissions.

The FDA has granted approval for ANDA077060, authorizing the prescription extended‑release metformin hydrochloride tablet (500 mg) marketed by Zydus Lifesciences.

The FDA has granted approval for an Abbreviated New Drug Application (ANDA) 076768 covering multiple strengths of alendronate sodium tablets, manufactured by Exelan Pharmaceuticals and Cipla USA.

FDA has approved Chartwell RX's generic allopurinol tablets (100 mg and 300 mg) under ANDA 077353, confirming prescription status and labeling updates.

The FDA record for NDA018025 shows the injectable form of furosemide marked as discontinued after a series of approved labeling and manufacturing supplemental submissions.

Abbott has revised the instructions for use of its Amplatzer Amulet left atrial appendage occluder to specifically contraindicate placement near the pulmonary artery and added guidance on distance assessment.

Abbott revises the Amulet™ Left Atrial Appendage Occluder instructions to specify pulmonary artery as a contraindicated adjacent structure and adds guidance on device‑to‑artery distance.

Health Canada has recalled Ethicon's PERMA-HAND™ Silk Suture after discovering an unapproved alcohol‑based tubing fluid in its primary packaging.

Ethicon recalls PERMA‑HAND™ Silk Suture after discovering an alcohol‑based tubing fluid was used in manufacturing.

The FDA granted approval (ANDA 084031) for BARR's sulfisozole 500 mg oral tablet, which is listed as discontinued. A labeling supplement was filed in 1995.

Sun Pharm Industries' quinidine sulfate tablet (200 mg) received FDA approval under ANDA081030, with manufacturing and labeling submissions approved between 1989 and 2010. The product is currently listed as discontinued.