Lupin received tentative U.S. FDA approval for its ANDA for Pitolisant Tablets in 4.45mg and 17.8mg strengths.
The product is bioequivalent to Wakix® and will be manufactured at Lupin's Nagpur facility in India.
Disclosure was filed under Regulation 30 of SEBI (LODR) Regulations, 2015 on March 25, 2026.