Hyderabad, July 14: Granules India Limited announced on Friday 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 the Granules Consumer Health (GCH) division., Granules India said in a release here.
Acetaminophen and Ibuprofen Tablets are used for temporary relief of minor aches and pains due to headaches, toothaches, backaches, menstrual cramps, muscular aches, and minor arthritis pain.
Granules has a total of 59 ANDA approvals from the US FDA (57 Final and 2 tentative approvals).
According to IRI multi-outlet market data, the Advil? Dual Action with Acetaminophen Tablets (OTC) brand and store brands had combined US sales of approximately $70 million in the most recent 12 months.
Advil is a registered trademark of GlaxoSmithKline Consumer Healthcare Holdings (US). (UNI)
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