Another FDA approval in Aurobindo's kitty

December 18, 2015 | Friday | News | By BioSpectrum Bureau

Another FDA approval in Aurobindo's kitty

The approval is for the strength 40 mg/vial, 125 mg/vial, 500 mg/vial, and 2 g/vial

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.

 

 

Comments

× Your session has expired. Please click here to Sign-in or Sign-up

Have an Account?

Forgot your password?

First Name should not be empty!

Last Name should not be empty!

Email address should not be empty!

Show Password should not be empty!

Show Confirm Password should not be empty!

Newsletter

E-magazine

Biospectrum Infomercial

Bio Resource

I accept the terms & conditions & Privacy policy