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Lupin Announces Approval from US FDA for Pitolisant Tablets

Lupin Announces Approval from US FDA for Pitolisant Tablets

Lupin has received the final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets, 4.45 mg and 17.8 mg.

The FDA has approved Lupin’s Pitolisant Tablets, 4.45 mg and 17.8 mg, as bioequivalent to Wakix for the indications in the approved labeling.
Read more on:
Abbreviated New Drug Application (ANDA) Generic Wakix Lupin Lupin Pharmaceuticals Pitolisant 17.8 mg Pitolisant 4.45 mg Pitolisant Tablets US FDA ANDA approval US FDA approval
More news about: regulation | Published by News Bureau | August - 17 - 2026

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