Aurobindo Pharma gets USFDA approval for Risedronate Sodium Tablets

01 Dec 2015 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Risedronate Sodium Tablets USP, 5 mg, 30 mg and 35 mg (ANDA 200296). This approval is an extension of tentative approval received on 10th October 2012. This product is ready for launch.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) ACTONEL Tablets of Warner Chilcott Co., LLC Risedronate Sodium Tablets are used in the treatment of Osteoporosis. The approved product has an estimated market size of $113 million for the twelve months ending October 2015.

The company now has a total of 219 ANDA approvals (191 Final approvals including 10 from Aurolife Pharma LLC and 28 Tentative approvals) from USFDA.

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, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.

 

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