FDA Approval for Lupin’s Pitolisant Tablets

Just announced from Lupin Limited: Lupin Announces Approval from U.S. FDA for Pitolisant Tablets

Mumbai, Naples, August 17, 2026: Global pharma major Lupin Limited (Lupin) today announced that it has received the final approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Pitolisant Tablets, 4.45 mg and 17.8 mg.

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