# Lupin gets USFDA nod for narcolepsy drug Pitolisant 2026-08-17T17:09:27+00:00 | Business & Economy | Indian Opinion Desk Corroboration: 1 independent outlet Drugmaker Lupin has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Pitolisant Tablets, 4.45 mg and 17.8 mg. The USFDA approved the generic as bioequivalent to Harmony Biosciences' brand drug Wakix. Wakix is a prescription medicine used to treat excessive daytime sleepiness or cataplexy in people aged 6 years and older with narcolepsy. The approval covers the indications listed in the branded drug's labelling. Lupin announced the development on August 17, 2026. The company did not immediately disclose a launch timeline or commercial partner for the product. ## Coverage - thehindu.com This story was synthesised by AI from the source linked above. Tags: Harmony Biosciences, Lupin, USFDA Canonical: https://indianopinion.org/lupin-gets-usfda-nod-for-narcolepsy-drug-pitolisant/ License: Summary and commentary (c) Indian Opinion, reusable with attribution. Facts belong to the linked sources. Cite: https://indianopinion.org/lupin-gets-usfda-nod-for-narcolepsy-drug-pitolisant/#story-in-brief Review state: restored archive article, accurate at time of publication, not offered to search indexes. How this brief was made: an AI model read the report linked above and wrote this summary and analysis, which were published automatically. Published briefs are sampled every hour by an automated quality check; the editor verifies its findings and approves corrections, and corrected briefs carry a dated correction line. We do no original reporting. Methodology: https://indianopinion.org/ai-use-policy/