Lupin gets US FDA approval for Pitolisant Tablets generic

Regulatory Product ApprovalBusiness Updates View source PDF Explain this filing

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AI summary

Lupin has received final approval from the US FDA for its generic Pitolisant Tablets in 4.45 mg and 17.8 mg strengths. The product is approved as bioequivalent to Wakix, used in treating narcolepsy. This strengthens Lupin's US generics portfolio and its central nervous system therapy segment, which is one of its key focus areas alongside respiratory and cardiovascular.

Likely market impact

Positive for US business. New generic approval can boost US revenue and strengthen Lupin's complex generics pipeline.