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.
