The Food and Drug Administration (FDA), September 7, 2005, announced the tentative approval of zidovudine oral solution manufactured by Aurobindo Pharma LTD. Hyderabad, India. This product is the first tentatively approved generic version of Retrovir brand of the zidovudine oral solution (manufactured by GlaxoSmithKline). This oral dosage form of the drug is the first pediatric-friendly oral solution available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).
Zidovudine is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. It is intended to be used with other antiretroviral agents for the treatment of HIV-1 infection. This product contains 50 mg/5mL of zidovudine in an oral solution.
Tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the United States, it meets all of FDA's quality, safety and efficacy standards for U.S. marketing.
FDA issues guidance for product sponsors
The Food and Drug Administration (FDA) is issuing draft guidance to assist product sponsors in the development of antiviral drug products and to serve as a starting point for understanding the nonclinical and clinical virology data important to support clinical trials of antiviral agents. This guidance focuses on nonclinical and clinical virology reports, which are essential components in the review of investigational antiviral drugs.
Topics in the guidance include studies defining the mechanism of action, establishing specific antiviral activity of the investigative drug, submitting data on the development of viral resistance to the investigational drug, and providing data identifying cross-resistance to approved drugs having the same target.
The recommendations in the guidance are based on the review experience with antiviral drugs of the FDA Division of Antiviral Drug Products (DAVDP) and input from pharmaceutical sponsors and the scientific community. Because of the experience, history, and lessons learned with HIV-1 studies, the guidance focuses on studies commonly used to evaluate HIV-1 drugs and uses them as a model for future studies of drugs to treat other viruses. Since the field of virology is dynamic and continually evolving, this guidance will be revised as new information accumulates and as circumstances warrant.
The Federal Register document, including instructions for submitting comments to the agency, is available at: www.fda.gov/OHRMS/DOCKETS/98fr/05-10431.htm
The draft guidance is available at http://www.fda.gov/cder/guidance/6568dft.htm.
FDA guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
The Food and Drug Administration (FDA), September 7, 2005, announced the tentative approval of zidovudine oral solution manufactured by Aurobindo Pharma LTD.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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