Dr Reddy's gets US nod for Prograf generic and expects 20 per cent in FY11
15 May 2010
After Sandoz, Dr Reddy's Laboratories has become the second company to gain the approval from US regulator to launch tacrolimus capsules, a generic equivalent of Japan's second-largest drug maker Astellas Pharma's Prograf, also sold under the brand name Advagraf by Astellas.
Sandoz, owned by Novartis, was the granted the first-to-market rights after it was approved the US FDA in August 2009.
Tacrolimus is an immunosuppressive treatment used to help prevent organ rejection like kidney or liver in a transplant, and was first approved by the FDA in 1994 for use in liver transplantation. It has now been extended to include kidney, heart, small bowel, pancreas, lung, trachea, skin, cornea, bone marrow, and limb transplants.
Dr Reddy plans to launch the drug in the US market next week, Reuters reported quoting a company spokesperson.
Prograf is now available in over 80 countries around the world. This indicates that Dr Reddy's market for this product is huge.
Japan's second-largest drugmaker Astellas Pharma manufactures the drug and introduced it in Indian market last year in June after it established its Indian office.