Aurobindo Pharma receives USFDA’s final approval for Alprazolam Extended-Release Tablets

08 Jun 2011 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Alprazolam Extended-Release Tablets 0.5mg, 1mg, 2mg, and 3mg. With this, the company has a total of 137 ANDA approvals (107 Final approvals and 30 tentative approvals) from USFDA.

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. The 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 $26.5 million for the twelve months ending September 2010, according to IMS and will be launched soon.

Aurobindo Pharma headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.

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