Lupin received U.S. FDA approval for its ANDA for Pitolisant Tablets (4.45 mg and 17.8 mg) as bioequivalent to Harmony Biosciences’ product. The approval supports near-term commercialization potential and is a positive regulatory milestone for Lupin, though the news doesn’t quantify financial impact.
Lupin received U.S. FDA approval for its ANDA for Pitolisant Tablets (4.45 mg and 17.8 mg) as bioequivalent to Harmony Biosciences’ product. The approval supports near-term commercialization potential and is a positive regulatory milestone for Lupin, though the news doesn’t quantify financial impact.
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