Impax Laboratories, Inc. announced that the US Food and Drug Administration (FDA) has granted final approval of the company's Abbreviated New Drug Application (ANDA) for generic versions of Xanax XR, (Alprazolam) 0.5 mg, 1 mg, 2 mg and 3 mg extended-release tablets.
Pharmacia and Upjohn markets Xanax XR for the management of anxiety disorder or the short-term relief of symptoms of anxiety. Impax' Global Pharmaceuticals division plans to launch the product soon.
US sales of the combined branded and generic 0.5 mg, 1 mg, 2 mg and 3 mg dosage forms were approximately $51 million in the 12 months ended March 2007, according to Wolters Kluwer Health.
"This is our third FDA approval this year and we are looking forward to adding our generic Xanax XR to the growing portfolio of our marketed products," said Larry Hsu, Ph.D., Impax's president and chief executive officer.
Impax Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax markets its generic products through its global pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division.