Lupin has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets, 4.45mg and 17.8mg.

The product would be manufactured at Lupin’s Nagpur facility.

The FDA has tentatively approved Lupin’s Pitolisant Tablets 4.45mg and 17.8 mg as bioequivalent to Wakix for the indication in the approved labeling.

Wakix is a registered trademark of Bioprojet Europe.

Lupin has 15 state-of-the-art manufacturing sites and seven research centres globally, along with a workforce of more than 22,000 professionals.