India, June 25 -- Lupin Ltd announced on Wednesday that it has received approval from the U.S. Food and Drug Administration (USFDA) for its generic version of Prucalopride tablets, used to treat chronic idiopathic constipation.
The approval covers Lupin's abbreviated new drug application (ANDA) for Prucalopride tablets in 1 mg and 2 mg strengths. According to the company's regulatory filing, the tablets are bioequivalent to Motegrity tablets (1 mg and 2 mg) developed by Takeda Pharmaceuticals USA Inc.
Published by HT Digital Content Services with permission from Dion Global Solutions Limited....