Indian Economy News

Lupin gets USFDA nod for generic tablets to treat excessive daytime sleepiness

Lupin Limited has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Pitolisant Tablets in strengths of 4.45 mg and 17.8 mg, indicated for the treatment of excessive daytime sleepiness (EDS). The approval allows Lupin to market a generic version of Pitolisant tablets in the US market. The company said the USFDA has approved its Pitolisant tablets as bioequivalent to Wakix, a prescription medicine used to treat excessive daytime sleepiness. Wakix is marketed by Harmony Biosciences. The approval strengthens Lupin’s generic pharmaceutical portfolio in the US and expands its offering of products used in the treatment of sleep-related conditions.

The USFDA approval covers the two specified strengths of Pitolisant tablets and follows the regulatory process for abbreviated new drug applications (ANDAs), through which generic medicines are assessed for equivalence to their reference products. Pitolisant is indicated for excessive daytime sleepiness, providing an additional generic treatment option in the US pharmaceutical market. The approval also reflects Lupin’s continued focus on expanding its portfolio of generic medicines across regulated international markets. With the US remaining an important market for Indian pharmaceutical companies, approvals for differentiated and specialised generic products can support portfolio expansion and strengthen companies’ presence in the global pharmaceutical market. The latest approval adds to Lupin’s US product portfolio while enabling the company to participate in the market for Pitolisant tablets in the approved strengths.

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