Aurobindo Pharma receives USFDA approval for methylprednisolone sodium succinate injection

The approved product has an estimated market size of $102 million for the twelve months ending October 2015 according to IMS

Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market methylprednisolone sodium succinate injection USP, 40 mg/vial, 125 mg/vial, 500 mg/vial, and 2 g/vial.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Solu-Medrol, of Pharmacia & Upjohn Co. Methylprednisolone sodium succinate injection is a lyophilised product used in the treatment of various medical conditions viz allergic states, disorders etc. The approved product has an estimated market size of $102 million for the twelve months ending October 2015 according to IMS.

This is the 19th ANDA (including one tentative approval) approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable products. Aurobindo now has a total of 224 ANDA approvals (196 Final approvals including 10 from Aurolife Pharma and 28 Tentative approvals) from US FDA.