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FDA Approves Generic AZT 300mg Tablets
 
 
  On February 14, 2008, FDA granted approval for a generic formulation of Zidovudine Tablets, 300 mg., manufactured by Matrix Laboratories, Inc. of Hyderabad, India. The application was reviewed under the expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR). However, because patent protections for the reference product, Retrovir Tablets,300 mg, made by GlaxoSmithKline have expired, this generic product can be marketed in the United States, as well as being available for purchase under the PEPFAR program.
 
A list of all FDA approved generic antiretroviral drugs for the treatment of HIV is available on the web at http://www.fda.gov/oashi/aids/viralsgeneric.html
 
Zidovudine is a Nucleoside Reverse Transcriptase Inhibitors (NRTI) indicated for the treatment of HIV in combination with other antiviral medications.
 
As with all FDA-approved generics, this product must meet all of FDA's manufacturing quality, and clinical safety and effectiveness standards.
 
Richard Klein
Office of Special Health Issues
Food and Drug Administration
 
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
 
 
 
 
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