Granules India has received the US Food & Drug Administration (USFDA) approval of 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 our Hyderabad facility and is expected to be launched shortly.
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., commenting on the approval.
Acetaminophen, Aspirin and Caffeine Tablets are indicated for the treatment of migraine.
Granules now has a total of 38 ANDA approvals from USFDA (37 Final approvals and 1 tentative approval) Excedrin is a trademark of GSK Consumer Healthcare S.A.
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