Staff Reporter : Mumbai, Naples, 17th August, 2026: Global pharma major Lupin Limited (Lupin) today announced that it has received the 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 labeling.
