Granules India Ltd’s Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine tablets has been approved by the US Food and Drug Administration (USFDA).
The approved ANDA is a bioequivalent to the reference listed drug product (RLD), Excedrin Migraine tablets of GlaxoSmithKline Consumer Healthcare. The product would be manufactured at our 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,’’ Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals Inc, said in a release.
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.