Lupin gets US FDA approval for Pitolisant Tablets

Global pharmaceutical major Lupin Limited has announced that it has received final approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets, 4.45 mg and 17.8 mg. The U.S. FDA has approved Lupin's Pitolisant Tablets as bioequivalent to Wakix® for the indications in the approved labeling. This approval marks a significant milestone for Lupin in the U.S. market, expanding its product portfolio and reinforcing its presence in the central nervous system therapeutic area.