Aurobindo Pharma gets US FDA OK for alprazolam extended-release

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Related tags: Controlled substances act

Drug maker Aurobindo Pharma has been cleared to make a generic equivalent of Pfizer’s CNS drug Xanax XR by the US FDA.

According to a filing on the Bombay Stock Exchange the firm has received final approval from the US Food and Drug Administration (FDA) to make and sell alprazolam extended-release tablets in four different doasage strengths.

Aurobindo told India’s Business Standard that: "The product has a market size of approximately $26.5 million for the twelve months ending September, 2010, according to IMS and will be launched soon.

The news follows just weeks after the firm announced it is considering demerging its API and formulation businesses to unlock value and better serve clients.

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