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U.S. Department of Health and Human Services

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HIV/AIDS Historical Time Line 1991-1994

 

1991  |  1992 | 1993  |  1994

 1991
  • On May 30, FDA authorized pre-approval distribution of dideoxycytidine (ddC) under a treatment IND protocol for the treatment of patients with AIDS or advanced AIDS Related Complex who cannot be maintained on zidovudine (AZT).
  • On September 27, FDA approved Foscavir (foscarnet) for use in the treatment of cytomegalovirus retinal infections in persons with AIDS.
  • On October 9, FDA approved Videx (didanosine, ddI) for the treatment of adult and pediatric patients (over 6 months of age) with advanced HIV infection. This approval involved the historic joint review between officials at FDA and our regulatory counterparts in Canada.
  • The first combination test to detect HIV-1 and HIV-2 antibodies was licensed.
  • On November 8, FDA authorized pre-approval distribution of atovaquone under a treatment IND protocol to patients who have Pneumocystis carinii pneumonia and cannot tolerate trimethoprim sulfamethoxazole, a standard treatment for this condition.
 1992
  • On March 6, FDA authorized pre-approval distribution of rifabutin under a treatment IND protocol for preventing or delaying the onset of Mycobacterium avium complex, a severe infection that often afflicts AIDS patients.
  • On May 27, FDA licensed SUDS HIV-1, a ten minute diagnostic test kit which can be used by health professionals to detect the presence of HIV-1.
  • On June 19, FDA approved zalcitabine, commonly known as ddC, for use in combination with zidovudine (AZT) as a treatment option for adult patients with advanced HIV infection who show signs of clinical or immunological deterioration. Zalcitabine, manufactured and distributed by Hoffmann-La Roche under the trade name Hivid, was the first drug approved under the principles and procedures of FDA's proposed accelerated drug approval policy.
  • On September 11, FDA approved Sporanox (itraconazole) for the treatment of blastomycosis and histoplasmosis in immunocompromised and non-immunocompromised patients.
  • On September 25, FDA approved new labeling for Videx (didanosine, ddI). The data demonstrated that the lower dose of ddI is equally efficacious and associated with lower rates of toxicity, especially pancreatitis.
  • On October 5, d4T (stavudine) was the first drug made available for expanded investigational use under the parallel track policy.
  • On October 8, FDA approved new labeling for nonprescription drugs for vaginal candidiasis. The revised labeling advised women that frequent or persistent cases of vaginal fungal infections may sometimes be an early warning of HIV infection.
  • On November 25, FDA approved Mepron (atovaquone) for the treatment of mild to moderate PCP in patients who are intolerant of trimethoprim-sulfamethoxazole, the standard therapy.
  • On December 22, FDA approved Marinol (dronabinol) for a new indication for the treatment of anorexia and weight loss associated with AIDS.
  • On December 23, FDA approved Mycobutin (rifabutin) for prophylaxis against Mycobacterium avium complex, a severe infection that often afflicts AIDS patients.
 1993
  • On May 7, FDA approved the Reality Female Condom which offers women a barrier product to protect themselves without relying on the cooperation of their partner.
  • On September 10, FDA approved Megace (megestrol acetate) for a new indication for the treatment of anorexia, cachexia, or an unexplained weight loss in patients with AIDS.
  • On December 14, FDA published an interim rule establishing a requirement for certain infectious disease testing, donor screening, and record keeping to help prevent the transmission of HIV and hepatitis b and C through human tissue used in transplantation.
  • On December 17, FDA approved Neutrexin (trimetrexate glucuronate) for the treatment of moderate to severe Pneumocystis carinii pneumonia.
  • On December 23, FDA approved Biaxin (clarithromycin) for a new indication for the treatment of disseminated mycobacterial infections due to Mycobacterium avium and Mycobacterium intracellular (Mycobacterium avium complex--MAC).
  • On December 27, FDA licensed Gamimune (Immune Globulin Intravenous (Human), (IGIV)) for use in HIV-infected children (a new indication) to decrease the frequency of bacterial infections, increase the time free from serious bacterial infections, and decrease the frequency of hospitalizations.
 1994
  • On January 7, FDA approved Bactrim and Septra (trimethoprim/sulfamethoxazole) for a new indication for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia.
  • On February 4, Secretary Shalala announced the eighteen members of the National Task Force on AIDS Drug Development, which includes experts in AIDS drug development issues from academia, industry, medicine, the HIV/AIDS-affected communities, and Government. The Chairman of the Task Force is the Assistant Secretary for Health. FDA provides administrative and managerial support for the Task Force.
  • On March 29, FDA asked condom manufacturers to begin using the air-burst test on all brands of latex condoms. This new test measures a condom's strength, and may be an indirect indicator of its resistance to breakage during use.
  • On March 29, FDA approved Sporanox (itraconazole) capsules for a new indication for the treatment of pulmonary and extrapulmonary aspergillosis in patients who are intolerant of or who are refractory to amphotericin B therapy.
  • On June 24, FDA approved Zerit (stavudine, d4T) for treatment of adults with HIV infection who no longer respond to or are intolerant of other antiviral drugs.
  • On August 5, FDA approved new labeling for Hivid (zalcitabine, ddC) to include use as monotherapy for HIV-infection in adults.
  • On August 8, FDA approved new labeling for Retrovir (zidovudine, AZT) to include use in preventing vertical transmission of HIV from HIV-infected pregnant women to their babies.
  • On November 7, FDA approved a polyurethane condom for use by individuals who are allergic to latex.
  • On November 23, FDA approved new labeling for Diflucan (fluconazole) to include pediatric patients with cryptococcal meningitis and candida infections.
  • On December 20, FDA authorized pre-approval distribution of Serostim, a mammalian derived recombinant human growth hormone, under a treatment IND protocol to patients with AIDS-related wasting.
  • On December 22, FDA approved Cytovene (oral ganciclovir) for the treatment of CMV retinitis in immunocompromised individuals.
  • On December 23, FDA approved the first non blood-based collection kit utilizing oral fluid for use in the detection of the antibody to HIV-1.