Regulatory Updates

FDA has approved Apotex's oral cilostazol tablets (50 mg and 100 mg) under ANDA 077030, adding a generic phosphodiesterase‑3 inhibitor to the market.

FDA granted approval for ANDA208181 covering oral tiagabine hydrochloride tablets (2 mg, 4 mg, 12 mg, 16 mg) submitted by Amneal Pharms Co.; all listed products are discontinued.

The FDA has approved application ANDA210272 for a buprenorphine transdermal patch, covering five dosage strengths and requiring a REMS program.

The FDA has approved the Padcev and Keytruda combination as the first muscle‑invasive bladder cancer therapy usable irrespective of cisplatin eligibility, for both neoadjuvant and adjuvant settings.

Sanofi's subcutaneous formulation of Sarclisa, Sarclisa Escena, received FDA approval, becoming the first injectable oncology drug deliverable via on-body injector.

The FDA has approved application ANDA078249 for torsemide oral tablets, manufactured by Aurobindo Pharma and Rising Pharma Holdings, covering strengths from 5 mg to 100 mg.

Sun Pharm Industries received FDA approval for an ANDA (ANDA081029) covering oral quinidine sulfate tablets (100 mg). The product is listed as discontinued, with multiple supplemental approvals for manufacturing and labeling.

The FDA has approved application ANDA079162 for generic topiramate oral tablets (25 mg, 50 mg, 100 mg, 200 mg) manufactured by Cipla USA Inc. and Exelan Pharmaceuticals.

Vera Therapeutics' atacicept, branded Trutakna, received FDA accelerated approval as the sixth therapy for IgA nephropathy, the first U.S. drug to block both BAFF and APRIL.

The FDA approved application ANDA080531 for a 5 mg oral prednisolone tablet marketed by Chartwell RX, LLC, with multiple manufacturing and labeling supplements authorized.

The FDA approved Apotex's OFLOXACIN OTIC (0.3% otic solution) under ANDA 076527, with original approval on Sep 28, 2007 and a labeling supplement on Aug 6, 2008.

The FDA has granted approval for ANDA077997, an intravenous caffeine citrate solution manufactured by Fresenius Kabi USA, now listed as a prescription drug.