U.S. FDA nod for Granules’ migraine drug

U.S. FDA nod for Granules’ migraine drug

The Hindu

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.
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