The approval is for the strength 40 mg/vial, 125 mg/vial, 500 mg/vial, and 2 g/vial
Aurobindo Pharma has received final approval from the US Food and 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 and Upjohn.
Methylprednisolone Sodium Succinate Injection is a lyophilized 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.