Actualizaciones regulatorias

The FDA has granted approval for Ohm Laboratories’ generic Valsartan tablets (40‑320 mg) under application ANDA 077492.

The FDA has granted approval for ANDA077183, a prescription oral capsule combining amlodipine besylate and benazepril hydrochloride, manufactured by Dr. Reddy's Laboratories.

The FDA has granted approval for Chartwell RX’s levofloxacin tablets in 250 mg, 500 mg and 750 mg oral strengths under ANDA 076890.

The FDA approved ANDA209102 for generic baclofen oral tablets in 5‑20 mg strengths, manufactured by TruPharma, Advagen Pharma and SOLA Pharmaceuticals.

The FDA granted approval for an OTC oral tablet of lansoprazole 15 mg under NDA 208025, listed under several brand names and marketed by multiple retailers.

FDA has approved ANDA207613, authorizing oral Midodrine Hydrochloride prescription tablets in 2.5 mg, 5 mg, and 10 mg strengths from Umasuto and Rising Pharma.

The FDA has approved the prescription transdermal patch TRANSDERM SCOP, containing 1 mg scopolamine per 72 hr, under NDA 017874. Baxter Healthcare is the manufacturer.

Revolution Medicines' RAS inhibitor daraxonrasib, branded Rasonque, was approved by the FDA for metastatic pancreatic cancer after ASCO data earned a standing ovation.

The FDA approved ANDA 084286 submitted by BARR for a 2 mg oral tablet of Triamcinolone. The product is listed as discontinued.

FDA has approved Oxford Pharm's abbreviated new drug application for generic simvastatin tablets in five strengths, all prescription oral products.

The FDA has approved ANDA085790 for an oral 100 mg Isoniazid tablet submitted by Watson Labs. The product is currently listed as discontinued.

The FDA granted approval (AP) for ANDA 076672, an oral gabapentin solution 250 mg/5 ml submitted by TARO. The product is listed as discontinued.