Lupin gets tentative approval for Pitolisant Tablets from USFDA

25 Mar 2026 Evaluate

Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Pitolisant Tablets, 4.45mg and 17.8mg. This product would be manufactured at Lupin’s Nagpur facility in India.

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

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

Lupin Share Price

2334.95 -12.50 (-0.53%)
27-Mar-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1795.65
Dr. Reddys Lab 1281.95
Cipla 1242.65
Zydus Lifesciences 896.60
Lupin 2334.95
View more..
Register Now to get our Free Newsletter & much more!

© 2026 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×