New Drug for Migraine Approved by Colleen Fleiss on February 25, 2021 at 8:03 AM
The US Food & Drug Administration (US FDA) has approved Granules 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.
‘Granules Abbreviated New Drug Application (ANDA) for acetaminophen, aspirin, and caffeine tablets, indicated for migraine treatment has been approved by USFDA. ’ 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 fi