Published On:June 11 2008
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Aurobindo gets nod from USFDA
Hyderabad: Aurobindo Pharma Ltd received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Zaleplon capsules in 5 mg and 10 mg dosages.
The capsules are the generic equivalent of King Pharmaceuticals’ Sonata capsules, which are indicated for the treatment of insomnia. The Hyderabad-based company is in the first line of generics and got the USFDA nod on the very first day post the expiry of the relevant patent.
It had already launched the product in the US market, according to a release. Zaleplon was Aurobindo’s 70th Abbreviated New Drug Approval approval from the USFDA, it added.