Lupin Receives FDA Approval for Generic Pitolisant Tablets

Global pharmaceutical company Lupin Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets, 4.45 mg and 17.8 mg. These tablets are approved as bioequivalent to Wakix®, indicated for narcolepsy and idiopathic hypersomnia.