Regulatorische Updates

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 approved ANDA087081 for a 0.2% nitrofurazone topical solution submitted by Wendt; 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 approved ANDA077053 for Ribavirin 200 mg oral tablets, sponsored by Heritage Pharma Avet. The product is listed with a discontinued marketing status.

FDA approved application ANDA078541 for a 0.1% mometasone furoate topical cream by Glenmark Pharmaceuticals. Original approval in 2008 with later labeling updates; product now discontinued.

The FDA approved ANDA077968 on May 24, 2007 for IMPAX Labs' oral extended‑release alprazolam tablets, all listed as discontinued products.

The FDA has approved ANDA 085767 for a 35 mg oral tablet of phendimetrazine tartrate submitted by Watson Labs; the product is listed as discontinued.

The FDA has approved Baxter Healthcare's intravenous potassium chloride, dextrose and sodium chloride injection (NDA018008) across several dosage strengths.

The FDA has approved ANDA077222 for generic fosinopril sodium oral tablets in 10 mg, 20 mg, and 40 mg strengths, sponsored by Invagen Pharms.

The FDA has approved ANDA076920 for Levetiracetam tablets (250 mg, 500 mg, 750 mg) manufactured by Dr. Reddy's Laboratories and sponsored by Pharmazone.

The FDA approved ANDA 076368 for two extended‑release potassium chloride tablets (10 mEq and 20 mEq) marketed by AdaRe Pharm and manufactured by Sun Pharmaceutical.