Lupin Receives Tentative Approval from U.S. FDA for Pitolisant Tablets

Global pharma major Lupin Limited has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Pitolisant Tablets, 4.45mg and 17.8mg. The product will be manufactured at Lupin’s Nagpur facility in India. The U.S. 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. Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. The company specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.