Lupin Secures USFDA Approval for Generic Pitolisant Tablets
Lupin Ltd said it received final USFDA approval for its generic Pitolisant tablets for treating excessive daytime sleepiness. The abbreviated new drug application covers strengths of 4.45 mg and 17.8 mg. Lupin’s tablets are bioequivalent to Harmony Biosciences’ Wakix, which is used as a prescription treatment for EDS.