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news.Lupin Pharmaceuticals (LPI) has received tentative approval for the company’s Abbreviated New Drug Application (ANDA) for Eszopiclone tablets, 1mg, 2mg and 3mg from FDA.
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Eszopiclone, marketed by Sepracor under the brand-name Lunesta, is a nonbenzodiazepine hypnotic agent (viz., a sedative) used as a treatment for insomnia. Eszopiclone is the active dextrorotatory stereoisomer of zopiclone, and belongs to the class of drugs known as cyclopyrrolones.
Eszopiclone is a short acting nonbenzodiazepine sedative hypnotic. It has been shown to be safe and effective for short-term treatment in the elderly and safe in younger adults for 6–12 months.
The company is planning to launch the product in the market through LPI’s network of national wholesalers and pharmacy chains post patent expiry in 2012.
Vinita Gupta, president and CEO of Lupin Pharma, said: “We are pleased to receive this tentative approval and look forward to bringing Eszopiclone tablets to the US market as an affordable generic alternative post patent expiry.”