Hyderabad, Feb 25: Granules India Limited announced on Wednesday  that the US Food & Drug Administration (USFDA) has approved its Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg/250 mg/65 mg (OTC).

It is bio-equivalent to the reference listed drug product (RLD), Excedrin Migraine Tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare, Hyderabad-based pharmaceutical company said in a release here.

The product would be manufactured at our Hyderabad facility and is expected to be launched shortly.

Commenting on the approval, Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc., said ” we received approval for this triple combination product within 14 months from filing and with this, we have received three ANDA approvals over the past month.”

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 S.A. (UNI)