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March 13, 1987

AZT (Zidovudine) Just a Step Away From FDA Approval for AIDS Therapy

JAMA. 1987;257(10):1281-1282. doi:10.1001/jama.1987.03390100015002

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AN ADVISORY COMMITTEE of the Food and Drug Administration (FDA), by a vote of ten to one, has recommended that the FDA commissioner approve the anti-viral drug azidothymidine (AZT) for the treatment of acquired immunodeficiency syndrome (AIDS).

The United States Adopted Name (USAN) designation for AZT, decided upon earlier this year, is zidovudine.

The drug has been shown to inhibit the enzyme that the AIDS virus uses to replicate in the cell. It also appears to have other advantages in the management of patients with AIDS, such as the ability to penetrate the blood-brain barrier.

The committee's action is not binding on the agency, but such advice always carries considerable weight. Given the present poor outlook for patients with AIDS and the lack of effective treatment for the disease, the agency is unlikely to reject the committee's recommendation.

Yet, even when approved, AZT will be restricted to those groups of