Aurobindo Pharma Ltd announced that the company has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market alprazolam extended-release tablets 0.5mg, 1mg, 2mg, and 3mg.
Alprazolam extended-release tablets 0.5mg, 1mg, 2mg, and 3mg is the generic equivalent to the reference listed drug Xanax XR tablets 0.5mg, 1mg, 2mg, and 3mg of Pharmacia and Upjohn. Alprazolam extended-release tablets are indicated for the treatment of panic disorder, with or without agoraphobia and fall under the central nervous system (CNS) therapeutic segment. The product has a market size of approximately US$ 26.5 million for the 12 months ending September 2010 according to IMS and will be launched shortly.
Aurobindo now has a total of 137 abbreviated new drug application (ANDA) approvals, including 107 final approvals and 30 tentative approvals, from the US FDA.