Lupin Gets Final FDA Approval for Pitolisant Tablets 4.45 mg and 17.8 mg
Lupin Limited announced it received final approval from the U.S. FDA for its Abbreviated New Drug Application for Pitolisant Tablets in 4.45 mg and 17.8 mg strengths. The FDA approved the tablets as bioequivalent to Wakix for the indications in the approved labeling, supporting Lupin’s presence in the U.S. market.