FDA gives tentative approval to Lunesta generic

BALTIMORE Lupin has received tentative approval for a generic version of a popular insomnia treatment.

Lupin has received tentatively approval for eszopiclone tablets in 1-mg, 2-mg and 3-mg strengths. The tablets are the generic equivalent of Sepracor's Lunesta.

Commenting on the approval, Vinita Gupta, president and CEO of Lupin Pharmaceuticals, 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 [in 2012]."

Lunesta garnered annual sales of approximately $761 million for the twelve months ended December 2009, based on IMS Health sales data.

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