Granules gets FDA nod for ache relieving drug
Pharmaceutical major headquartered in Hyderabad, Granules India Limited on Friday announced that the US Food and Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC).
Granules gets FDA nod for ache relieving drug
Hyderabad Pharmaceutical major headquartered in Hyderabad, Granules India Limited on Friday announced that the US Food and Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC).
The ANDA was filed by Granules Pharmaceuticals, Inc (GPI), a wholly-owned foreign subsidiary of the company. The medicine 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. 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 two 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 around $70 million in the most recent 12 months. Advil is a registered trademark of GlaxoSmithKline Consumer Healthcare Holdings (US).
