Granules India Receives USFDA nod for OTC Equivalent of Advil Dual Action Tablets

Granules India Limited announced that the US Food and Drug Administration (USFDA) has approved the company's Abbreviated New Drug Application (ANDA). Granules Pharmaceuticals, Inc. (GPI), a subsidiary of Granules India Limited, filed the application. Acetaminophen and Ibuprofen Tablets, with a strength of 250 mg/125 mg, are approved and available over the counter (OTC). The US Food and Drug Administration has confirmed that this medication is the same as Advil® Dual Action with Acetaminophen Tablets, which are manufactured by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.

Granules India Limited intends to launch this product through its Granules Consumer Health (GCH) division. Acetaminophen and Ibuprofen tablets are medications used to treat minor aches and pains caused by headaches, toothaches, backaches, menstrual cramps, muscle aches and minor arthritis pain. The company has received 59 approvals for Abbreviated New Drug Applications (ANDAs) from the US Food and Drug Administration (USFDA). There are 57 final approvals and two tentative approvals. Based on market data from IRI, a firm that tracks sales in various outlets, the combined sales of the brand Advil Dual Action with Acetaminophen tablets and store-brand versions in the United States was around $70 million in the past year.