New Delhi: Glenmark Pharmaceuticals Ltd has received final approval from the United States Food Drug Administration (USFDA) for Acetaminophen and Ibuprofen tablets, 250 mg/125 mg (OTC).
The regulatory authority has determined these tabletes as bioequivalent to Advil Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), of Haleon US Holdings.
Currently Glenmark’ portfolio consists of 195 authorized products authorized for distribution in the market while 52 ANDAs (new drug applications) more are awaiting approval by the USFDA.
According to the US State department records Acetaminophen tablets are used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, reactions to vaccinations (shots), and to reduce fever as well.