Lupin receives USFDA approval for Pitolisant Tablets
The approval covers Pitolisant Tablets 4.45 mg and 17.8 mg, bioequivalent to Wakix for the indications in the approved labelling
Lupin has received final approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Pitolisant Tablets, 4.45 mg and 17.8 mg.
The U.S. FDA has approved Lupin’s Pitolisant Tablets, 4.45 mg and 17.8 mg, as bioequivalent to Wakix for the indications in the approved labelling.