Lupin receives tentative approval from US FDA for Pitolisant tablets
The product would be manufactured at Lupin’s Nagpur facility in India.
Global pharma major Lupin announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Pitolisant tablets, 4.45 mg and 17.8 mg. This product would be manufactured at Lupin’s Nagpur facility in India.
The US FDA has tentatively approved Lupin’s Pitolisant Tablets 4.45 mg and 17.8 mg as bioequivalent to Wakix for the indication in the approved labeling.