In a significant achievement for Nagpur’s pharmaceutical sector, global pharma major Lupin Limited has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets in 4.45 mg and 17.8 mg strengths, which will be manufactured at Lupin’s Nagpur facility.
Pitolisant is indicated for the treatment of excessive daytime sleepiness in patients suffering from narcolepsy, including adults and children aged six years and above. It is also used to treat cataplexy — sudden episodes of muscle weakness — in adults with narcolepsy. The drug belongs to a class known as H3 receptor antagonists and works by regulating neurotransmitters involved in sleep-wake cycles.
The company confirmed that its product is bioequivalent to Wakix, meeting all regulatory standards set by the US FDA. Wakix, sold by Harmony Biosciences, first received US FDA approval in August 2019 and has since exceeded $2 billion in cumulative net revenue. Lupin’s generic version is expected to offer a more affordable alternative in the American market.
Lupin’s Nagpur facility previously received an Establishment Inspection Report with a Voluntary Action Indicated classification from the US FDA, signalling satisfactory manufacturing operations.
Lupin is a global pharmaceutical leader headquartered in Mumbai, with products distributed in over 100 markets. This approval further cements Nagpur’s MIHAN zone as a growing hub of world-class pharmaceutical manufacturing.
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