The U.S. Food and Drug Administration (U.S. FDA) has accepted the abbreviated new drug utility filed by drugmaker Granules India’s subsidiary Granules Pharmaceuticals Inc for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC).
The product is bioequivalent to the reference listed drug Advil Dual Action with Acetaminophen tablets, 250mg/125 mg (OTC) of GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ,and can be unveiled by means of Granules’ Consumer Health division.
The Advil Dual Action with Acetaminophen tablets (OTC) model and retailer manufacturers had a mixed U.S. gross sales of about $70 million for the latest 12 months primarily based on IRI multi-outlet market information, Granules mentioned on Friday.
Acetaminophen and Ibuprofen tablets are used for momentary aid for minor aches and pains as a consequence of headache, toothache, backache, menstrual cramps, muscular aches, minor ache of arthritis, the corporate mentioned. Granules India shares rose 2.08% to shut at ₹308.65 every on the BSE.
