India, March 25 -- Lupin Limited has received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets in strengths of 4.45 mg and 17.8 mg.
The approved product is a generic version of Wakix® and is indicated as per the approved labeling. The tablets will be manufactured at Lupin's Nagpur facility in India.
Published by HT Digital Content Services with permission from Dion Global Solutions Limited....