HYDERABAD: City-based Granules India Ltd made an announcement regarding the approval of its new medicine by the US Food & Drug Administration (US FDA), on Friday. The medicine, Acetaminophen-Ibuprofen tablets, has been granted approval with a strength of 250 mg/125 mg.
This approval allows the tablet to be prescribed for over-the-counter use as well. The medication is intended for temporary relief of minor aches and pains, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and minor arthritis pain.
The company revealed that the FDA approved its Abbreviated New Drug Application (ANDA), which included comprehensive data for review. Granules Pharmaceuticals, Inc., a subsidiary of Granules India Limited, submitted the application. The product will be launched through the Granules Consumer Health (GCH) division.
Granules highlighted that the approved tablet is bioequivalent to the Advil® Dual Action with Acetaminophen Tablets, 250 mg/125 mg, manufactured by GlaxoSmithKline Consumer Healthcare Holdings.
According to market data, Advil® Dual Action with Acetaminophen Tablets, along with store brands, achieved combined sales of approximately $70 million in the recent twelve months. This latest approval marks an important milestone for Granules India, bringing their total number of ANDA approvals from the FDA to 59, including 57 final approvals and 2 tentative approvals.