Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Methylprednisolone Sodium Succinate Injection USP, 40 mg/vial, 125 mg/vial, 500 mg/vial, and 2 g/vial.
[adsense:336x280:8701650588]
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 lyophilized product used in the treatment of various medical conditions viz allergic states, disorders etc. The approved product has an estimated market size of US$102 million for the twelve months ending October 2015 according to IMS.
[adsense:468x15:2204050025]
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 LLC and 28 Tentative approvals) from USFDA.
