Aurobindo receives US FDA approval for Simvastatin

Aurobindo Pharma is proud to announce that the US FDA has granted tentative approval for Aurobindo’s Simvastatin Tablets USP 5 mg, 10 mg, 20 mg, 40 mg and 80 mg.

Zocor®, Merck’s brand name for Simvastatin, is the second largest brand in USA with over USD 5 Billion annual sales and is one of the fast growing brand. Simvastatin Tablets USP is going off patent on 23rd June 2006 and is indicated for the treatment of high cholesterol.

This is a significant approval for Aurobindo Pharma.

Aurobindo manufactures both API and formulations for Simvastatin Tablets USP 5 mg, 10 mg, 20 mg, 40 mg and 80 mg.

Approval of Simvastatin, known to be a difficult product requiring intense R & D capabilities, once again demonstrates the R & D skills of Aurobindo Pharma.