Aurobindo Pharma receives approval from USFDA for Carisoprodol Tablets

Aurobindo Pharma has received the final approval for Carisoprodol Tablets USP 500 mg from the US Food & Drug Administration (USFDA).

Carisoprodol Tablets USP 500 mg is the generic equivalent to Soma Tablets USP 350 mg of Meda Pharmaceuticals. These tablets are muscle relaxants and indicated as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.

The product has a market size of approximately $98 million for the 12 months ending March 2009 according to Newport.

Aurobindo now has total of 100 ANDA approvals which comprises of 71 final approvals and 29 tentative approvals from USFDA. The company has received 100 approvals in very short span, the first ANDA approval being received in October 2004.

Aurobindo Pharma is manufacturer of generic pharmaceuticals and active pharmaceuticals ingredients. The company’s product portfolio is spread over in 6 major therapeutic areas encompassing antibiotics, anti-retroviral, cvs, cns, gastroenterological and anti allergic.