Lupin gets USFDA nod for Paliperidone Extended-Release Tablets

1 Jul 2022 , 10:31 AM

Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Paliperidone Extended-Release Tablets 1.5 mg, 3 mg, 6 mg, and 9 mg, to market a generic equivalent of Invega Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg, of Janssen Research and Development, LLC.

The product will be manufactured at Lupin’s facility in Goa, India, said the company.

Further, Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S. (IQVIA MAT March 2022).

At around 10:34 AM, Lupin was trading at Rs612.15 per share up by Rs0.75 or 0.12% from its previous closing of Rs611.40 per share on the BSE.