U.S. FDA gives nod for Granules copy of GlaxoSmithKline’s Advil Dual Action tablets 

July 14, 2023 08:42 pm | Updated July 17, 2023 02:27 pm IST - HYDERABAD

The U.S. Food and Drug Administration (U.S. FDA) has approved the abbreviated new drug application filed by drugmaker Granules India’s subsidiary Granules Pharmaceuticals Inc for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC).

The product is bioequivalent to the reference listed drug Advil Dual Action with Acetaminophen tablets, 250mg/125 mg (OTC) of GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ,and will be unveiled through Granules’ Consumer Health division.

The Advil Dual Action with Acetaminophen tablets (OTC) brand and store brands had a combined U.S. sales of about $70 million for the most recent 12 months based on IRI multi-outlet market data, Granules said on Friday.

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 company said. Granules India shares rose 2.08% to close at ₹308.65 each on the BSE.

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