Friday, June 27, 2008

HIV/AIDS Update - Zidovudine Oral Solution USP, 50 mg/5 mL Generic Product Approval

On June 26, 2008, FDA granted approval for a generic Zidovudine Oral Solution USP, 50 mg/5 mL formulation manufactured by Cipla Limited of of Mumbai, India. The is a full approval, meaning that this generic zidovudine formulation can be marketed in the United States. The application was reviewed under the expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR).

The details can be read here.

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