U.S. FDA nod for Granules’ migraine drug

The U.S. Food and Drug Administration has approved Granules India’s Abbreviated New Drug Application for Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg/250 mg/65 mg (OTC).

The company said the approved product is bioequivalent to the reference listed drug, Excedrin Migraine Tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare. It will be manufactured at its Hyderabad facility and is expected to be unveiled shortly. Acetaminophen, Aspirin and Caffeine tablets are indicated for migraine treatment.

Executive Director of Granules Pharmaceuticals Inc Priyanka Chigurupati said the company is focusing on building a sustainable OTC product portfolio in the U.S. market. The approval for the triple combination product was received within 14 months from filing. “With this, we have received three ANDA approvals over the past month,” she said.