Aurobindo gains FDA approval for alprazolam tablets

DAYTON, N.J. — Aurobindo Pharma Limited on Tuesday received approval from the Food and Drug Administration for its alprazolam tablets, a generic version of Xanax. The FDA approved Aurobindo’s alprazolam tablets in 0.25- 0.5-, 1- and 2-mg dosage strengths.

Alprazolam is used to treat anxiety disorders, panic disorders and anxiety caused by depression. As a benzodiazepine, it slows down the movement of chemicals in the brain that may become unbalanced, resulting in a reduction in nervous tension.

The product has an estimated market size of $102.7MM for the 12 months ending in June 2015, according to IMS Health data.