India, March 25 -- 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 stated that the approved product is bioequivalent to Wakix, as per the approved labeling by the U.S. regulator. The tablets will be manufactured at Lupin's facility in Nagpur, India.
Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializ...
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