Mumbai: Drug maker Lupin Ltd on Monday said its US-based arm Lupin Pharmaceuticals has received a tentative approval from the US health regulator for Eszopiclone tablets used in the treatment of sleep disorder.
The company has received a tentative approval for the company’s abbreviated new drug application (ANDA) for Eszopiclone tablets from the US Food and Drug Administration (USFDA), Lupin said in a filing to the Bombay Stock Exchange (BSE).
“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,” Lupin Pharmaceuticals president and CEO Vinita Gupta said.
Eszopiclone tablets are available in the strength of 1 mg, 2 mg and 3 mg, the filing added.
The product would be introduced in the market through Lupin Pharmaceuticals strong network of national wholesalers and pharmacy chains post patent expiry in 2012, it said.