Aurobindo receives USFDA approval for Alprazolam extended-release tablets
08 Jun 2011
Aurobindo Pharma Limited has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Alprazolam extended-release tablets (0.5mg, 1mg, 2mg, and 3mg) in the US market.
Alprazolam extended-release tablet (0.5mg, 1mg, 2mg, and 3mg) is the generic equivalent of the reference listed drug Xanax XR tablet (0.5mg, 1mg, 2mg, and 3mg) of Pharmacia and Upjohn. It will soon be launched in the US market.
The drug is indicated for the treatment of panic disorder, with or without agoraphobia and fall under the central nervous system (CNS) therapeutic segment. The product had US sales of approximately $26.5 million for the twelve months ended September 2010, according to IMS.
Aurobindo now has a total of 137 ANDA approvals (107 final approvals and 30 tentative approvals) from USFDA
Hyderabad-based Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients.
The company's product portfolio covers six major therapeutic/product areas, including antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals and anti-allergics, supported by an outstanding R&D set-up.
The company's manufacturing facilities are approved by several leading regulatory agencies, including US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. The company markets its products in over 125 countries.