Regulatorische Updates

The FDA has approved application ANDA083919 for MILTOWN, an oral tablet containing 600 mg of meprobamate, sponsored by Medpointe Pharm HLC.

The FDA records show multiple approved supplemental submissions for the discontinued 200 mg oral tablet of quinidine sulfate, covering manufacturing and labeling.

The FDA has approved a series of priority manufacturing (CMC) supplement submissions for the discontinued LIORESAL baclofen tablets (10 mg and 20 mg).

FDA approves ANDA 088184 for Hydroxyzine Hydrochloride injectable product by Fresenius Kabi USA, with multiple labeling and manufacturing submissions.

FDA records show approved manufacturing and labeling submissions for the discontinued oral tablet HYDROCODONE BITARTRATE AND ACETAMINOPHEN (500 mg/7.5 mg).

The FDA has approved several manufacturing (CMC) supplement submissions for Sandoz’s Orphenadrine Citrate extended‑release tablet (ANDA 085046), which is currently listed as discontinued.

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

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

The FDA approved ANDA080713 for Watson Labs' oral tablet TripeLennaMine Hydrochloride 50 mg, now listed as discontinued, with a history of multiple supplemental approvals.

FDA approved three manufacturing supplement submissions for Isoniazid tablets (50 mg and 100 mg) under ANDA080132; both products are listed as discontinued.

The FDA has approved a series of manufacturing (CMC) and labeling submissions for the discontinued oral chlorthalidone 25 mg tablet (product 001, ANDA 087292).

The FDA has approved ANDA 088371 for a cyclophosphamide injectable product (100 mg/vial) marketed by Baxter Healthcare, with multiple manufacturing and labeling submissions approved.