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Lupin gets USFDA’s final nod for Pitolisant Tablets

17 Aug 2026 Evaluate

Lupin has received the final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application for Pitolisant Tablets, 4.45 mg and 17.8 mg. The USFDA has approved the company’s Pitolisant Tablets, 4.45 mg and 17.8 mg, as bioequivalent to Wakix for the indications in the approved labeling.

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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