Lupin (NSE:LUPIN, BOM:500257) said the U.S. Food and Drug Administration granted final approval for its abbreviated new drug application for Pitolisant Tablets 4.45 mg and 17.8 mg, according to a filing to Indian bourses.
The tablets have been approved as bioequivalent to Wakix, which is approved in the U.S. for the treatment of narcolepsy.
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