Granules India Ltd on Wednesday announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for acetaminophen, aspirin, and caffeine tablets, indicated for the treatment of migraine.
It is bioequivalent to the Reference Listed Drug (RLD) product, Excedrin Migraine tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare.
The product would be manufactured at Granules India’s Hyderabad facility and is expected to be launched shortly.
“We are pleased to announce approval of Acetaminophen, Aspirin and Caffeine tablets, emphasising our focus on building a 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, Inc.
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 S.A.