Orchid Healthcare, a division of Orchid Chemicals & Pharmaceuticals received tentative approval for the Abbreviated New Drug Application (ANDA) from US Food and Drug Administration (USFDA) for the Eszopiclone tablets in the multiple strengths of 1 mg, 2 mg, 3 mg.
It was originally developed and marketed by the Sepracor under the brand name drug Lunesta. The branded drug had annual sales of USD 787 million for the 12 months ended September 2010. Further, the patent is set to expire in 2014.
The drug indicated for the treatment of insomnia. Lupin, Mylan Pharma, Glenmark generics have already received tentative approval form US FDA.
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