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HIV/AIDS Update – Approval of generic stavudine for oral solution, 1 mg/mL

On March 20, 2009, the Food and Drug Administration (FDA) approved a generic formulation of stavudine for oral solution, 1 mg/mL. Stavudine is a Nucleoside Reverse Transcriptase Inhibitor (NRTI) indicated for used in combination with other antiretroviral agents in the treatment of HIV infection. This child-friendly product, manufactured by Cipla, Limited, of Mumbai, India, is indicated for use in pediatric patients with HIV from birth through adolescence.

A tentative approval was granted on October 29, 2007 for this product.  At that time, existing patent protections prevented full approval for marketing in the United States.

Because patent protection has since expired for the originator product, Zerit® for oral solution, 1 mg/mL, made by Bristol Myers Squibb, the generic product qualifies for approval. Effective patent dates for FDA approved drugs can be found in the agency’s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the “Orange Book.

Richard Klein
of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration


March 25, 2009 - Posted by | 1

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