Granules India gets USFDA approval for OTC Acetaminophen, Aspirin and Caffeine Tablets

Granules India announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg/250 mg/65 mg (OTC). It is bioequivalent to the reference listed drug product (RLD), Excedrin Migraine Tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare. The product would be manufactured at its Hyderabad facility and is expected to be launched shortly.

“We are pleased to announce approval of Acetaminophen, Aspirin and Caffeine Tablets, emphasizing our focus on building sustainable OTC product portfolio in the US market. We received approval for this triple combination product within 14 months from filing. With this, we have received three ANDA approvals over the past month,” said Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals.

Acetaminophen, Aspirin and Caffeine Tablets are indicated for the treatment of migraine.

Granules now has a total of 38 ANDA approvals from US FDA (37 Final approvals and 1 tentative approval).

Excedrin is a trademark of GSK Consumer Healthcare.