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The US Food & Drug Administration (USFDA) has approved an Abbreviated New Drug Application (ANDA), filed by Granules Pharmaceuticals, Inc (GPI), a wholly owned foreign subsidiary of Granules India for Acetaminophen and Ibuprofen tablets.
It is bioequivalent to the reference listed drug (RLD), Advil Dual Action with Acetaminophen tablets, manufactured by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.
Also read: Granules India completes FDA inspection in two facilities
“This product will be launched through Granules Consumer Health (GCH) division. Acetaminophen and Ibuprofen tablets are used for temporary relief for minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis,’‘ the Hyderabad-based company said in a release on Friday.
Granules now have a total of 59 ANDA approvals from the USFDA (57 final approvals and 2 tentative approvals). The Advil Dual Action with Acetaminophen tablets (OTC) brand and store brands had combined U.S. sales of approximately $70 million for the most recent twelve months based on IRI multi-outlet market data.
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