Regulatorische Updates

FDA has approved multiple manufacturing and labeling submissions for discontinued chlorpromazine hydrochloride tablets, noting the discontinuations were not due to safety or effectiveness concerns.

The FDA has granted approval for Alembic Pharmaceuticals’ generic lithium carbonate oral capsules in 150 mg, 300 mg, and 600 mg strengths under ANDA 079159.

The FDA has approved ANDA078845 for a 600 mg oral linezolid tablet marketed by Rising Pharma Holdings, Inc.

The FDA has marked the testosterone injectable (product 001) as discontinued, with a record of multiple labeling and manufacturing submissions dating back to 1983.

The FDA approved ANDA087081 for a 0.2% nitrofurazone topical solution submitted by Wendt; the product is listed as discontinued.

FDA approved ANDA085911 for an oral tablet containing 5 mg oxycodone and 500 mg acetaminophen, submitted by Bristol Myers Squibb; the product is listed as discontinued.

The FDA has granted approval (ANDA077941) for Apotex's injectable furosemide 10 mg/mL, classified as a prescription product.

The FDA has approved ANDA077652 for levofloxacin tablets (250 mg, 500 mg, 750 mg) manufactured by Zydus Lifesciences and Viona Pharmaceuticals.

The FDA has approved ANDA077345 submitted by Heritage Pharma Avet for oral sertraline hydrochloride tablets in 25 mg, 50 mg and 100 mg strengths. All listed products are currently marked discontinued.

The FDA approved ANDA077053 for Ribavirin 200 mg oral tablets, sponsored by Heritage Pharma Avet. The product is listed with a discontinued marketing status.

FDA has approved several labeling supplements for the discontinued oral capsule products of Loxapine Succinate under ANDA076762.

FDA granted approval for ANDA076481, a prescription 0.1% mometasone furoate topical ointment manufactured by Encube Ethicals, Inc.