Granules India arm bags USFDA nod for Acetaminophen and Ibuprofen Tablets

Hyderabad: Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA), filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of the company, for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC).

It is bioequivalent to the reference listed drug (RLD), Advil Dual Action with Acetaminophen Tablets, 250mg/125 mg (OTC), of GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.

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.

Medical Dialogues team had earlier reported that Marksans Pharma Ltd., a provider of consumer self-care products had also received final approval from the USFDA for its ANDA for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg, OTC bioequivalent of Advil Dual Action Tablets 250 mg/125 mg.

Read also: Marksans Pharma bags USFDA nod for Acetaminophen, Ibuprofen Tablets

Granules now have a total of 59 ANDA approvals from the US FDA (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. Advil is a registered trademark of GlaxoSmithKline Consumer Healthcare Holdings (US).