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.