Actavis receives FDA marketing approval for Alprazolam ODT

Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the U.S. Food & Drug Administration to market Alprazolam orally disintegrating tablets. Distribution of the product will commence immediately.  

"We're very pleased to add Alprazolam ODT to our portfolio and complete our Alprazolam family of offerings, which also includes Alprazolam extended-release and immediate release tablets," said Actavis Inc. CEO Doug Boothe.  

Alprazolam ODT, the generic equivalent of Niravam®, will be available in 0.25 mg, 0.5 mg, 1.0 mg, and 2.0 mg strengths. Alprazolam orally disintegrating tablets are indicated for the management of anxiety disorder or the short-term relief of symptoms of anxiety. U.S. sales of Niravam® and generic equivalents totaled $12.4 million for the 12 months ending December 2009, according to IMS Health data.

SOURCE Actavis