Date: June 1, 1996
Source: Food and Drug Administration (FDA)
FDA received first IND submission for treatment of AIDS.
AIDS identified as being caused by a human retrovirus, Human Immunodeficiency Virus (HIV).
FDA approved first enzyme linked immunosorbant assay (ELISA) test kit to screen for antibodies to HIV.
On March 19, FDA approved AZT - the first drug approved for the treatment of AIDS.
- On April 29, FDA approved the first Western blot blood test kit - a more specific test.
- On August 18, FDA sanctioned the first human testing of a candidate vaccine against HIV.
- Published regulations which require screening all blood and plasma collected in the U.S. for HIV antibodies.
- FDA completed studies demonstrating the safety of immune globulin products. The efficacy of viral inactivation and partitioning during manufacturing procedures was confirmed.
- FDA revised its strategy for the regulation of condoms by strengthening its inspection of condom manufacturers and repackers, strengthening its sampling and testing of domestic and imported condoms in commercial distribution, and providing guidance on labeling of condoms for the prevention of AIDS.
On February 12, Trimetrexate was the first AIDS drug to be granted pre-approval distribution status under the new Treatment IND regulations. Trimetrexate was used to treat Pneumocystis carinii pneumonia in AIDS patients who can not tolerate standard forms of treatment.
- On November 21, FDA licensed Intron A and Roferon A (human interferon alpha injection) for the treatment of Kaposi's Sarcoma, a cancer resulting from HIV.
- On November 28, FDA authorized pre-approval distribution of ganciclovir under a treatment IND protocol for the treatment of cytomegalovirus retinitis in AIDS patients.
- FDA doubled blood facility inspection effort with the inspection of 100 percent of FDA-regulated blood and plasma donor facilities.
- FDA implemented new regulations designed to make promising therapies available sooner for patients with life-threatening and severely-debilitating diseases.
On February 3, FDA authorized pre-approval distribution of aerosolized pentamidine under a treatment IND protocol for the prevention of Pneumocystis carinii pneumonia.
- On June 15, FDA approved NebuPent (aerosolized pentamidine) for the prevention of Pneumocystis carinii pneumonia.
- On June 23, FDA approved Cytovene (ganciclovir) infusion for use in the treatment of cytomegalovirus retinal infections in persons with AIDS.
- On June 27, FDA authorized pre-approval distribution of erythropoietin (EPO) under a treatment IND protocol for the treatment of zidovudine (AZT) related anemia in HIV positive patients.
- On September 28, FDA approved Retrovir (zidovudine, AZT) in syrup formulation.
- On September 28, FDA authorized pre-approval distribution of dideoxyinosine (ddI) under a treatment IND protocol for the treatment of patients with AIDS or AIDS Related Complex who are intolerant to zidovudine (AZT).
- Licensed the first diagnostic kit to detect the presence of HIV-1 by directly detecting the proteins, or antigens, of the virus.
- Participated in the establishment of an AIDS Clinical Trial Information Service (ACTIS), a computerized listing of information on AIDS-related clinical trials available via toll free telephone service.
- On October 26, FDA authorized pre-approval distribution of Retrovir (zidovudine, AZT) under a treatment IND protocol for the treatment of pediatric patients with HIV disease.
On January 29, FDA approved Diflucan (fluconazole) tablets to treat two serious AIDS-related fungal infections (Cryptococcal meningitis and candidiasis).
- On February 2, FDA approved Retrovir (zidovudine, AZT) in an intravenous dosage form.
- Expanded labeling for Retrovir (zidovudine, AZT) was approved, including dosage (January 1990), for use in early HIV disease (March 1990), and for use with children (May 1990).
- On December 31, FDA approved Epogen (erythropoietin, EPO) for the treatment of zidovudine-related anemia.
- FDA granted a license for the Recombigen HIV-1 EIA HIV antibody detection kit, designed for high volume screening sites.
- Novopath HIV-1 Immunoblot test for the detection of antibodies to individual proteins of HIV-1 approved. This test is nearly 5 times faster than comparable tests using the same technology.
- On December 12, FDA published a final rule defining acceptable quality levels for medical gloves and establishing the sampling plans and test methods that FDA will use to determine whether gloves are adulterated.
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.
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 a new indication for use in HIV-infected children to decrease the frequency of bacterial infections, increase the time free from serious bacterial infections, and decrease the frequency of hospitalizations.
On February 8, FDA approved Mepron (atovaquone) for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in patients who are intolerant to trimethoprim-sulfamethoxazole (TMP-SMX).
- On February 23, FDA revised the guidance for Home Specimen Collection Kit Systems Intended for Human Immunodeficiency Virus (HIV-1 and/or HIV-2) Antibody Testing.
- On March 24, FDA cleared for marketing the first blood test to measure latex antibodies in the blood. The test can be used to help identify people who are allergic to latex and as such assist people in the use of barrier products to prevent HIV transmission.
- On April 14, FDA approved Chartex International plc. London, U.K. premarket approval application for the Femidom Female Condom. The product is an intravaginal barrier device and is indicated for use to help prevent pregnancy, which will be used as an indicator of the device's performance in preventing STDs.
- In June 1995, FDA published "An FDA Guide To Choosing Medical Treatments," FDA Consumer.
- In June 1995, FDA allowed the initiation of an open label study for saquinavir for the treatment of HIV infection and AIDS. Saquinavir, manufactured by Hoffmann-La Roche, is the first protease inhibitor made available outside of ongoing clinical trials.
- On June 6, FDA revised the blood donor criteria to exclude prisoners from donating blood, blood components and plasma for 12 months from the last date of incarceration.
- On June 16, FDA approved Foscavir (foscarnet) for the treatment of acyclovir-resistant herpes simplex virus.
- On February 21, FDA approved a supplemental indication for Sporanox (itraconazole) for the treatment of oropharyngeal and esoplogeal candidiasis.
- On March 14, FDA granted accelerated approval for Viracept (nelfinavir) the first protease inhibitor labeled for use in children, as well as adults.
- On March 14, FDA approved pediatric labeling for the protease inhibitor Norvir (ritonavir).
- On April 4, FDA granted accelerated approval for Resciptor (delavirdine), a non-nucleoside reverse transcriptase inhibitor (NNRTI), for use in combination with other antiretroviral drugs for the treatment of HIV-1.
- On June 11, FDA issued a Public Health Advisory regarding reports of diabetes and hyperglycemia in patients receiving protease inhibitors for the treatment of HIV-1.
- On August 4, FDA approved Taxol (paclitaxel) for second line treatment of AIDS-related Karposi's Sarcoma.
- On September 17, FDA approved Famvir (famciclovir) for the suppression of recurrent episodes of genital herpes in immunocompetent adult.
- On September 26, FDA approved Combivir, a combined form of AZT and 3TC, two previously approved antiretroviral drugs for the treatment of HIV-1.
- On September 26, FDA warns consumers and pharmacists about two unapproved, fraudulently marketed home-use test kits which were advertised on the Internet for home HIV and Hepatitis A testing.
- On September 26, FDA issued a final rule requiring labeling of latex condoms to contain an expiration date based upon physical and mechanical testing performed after exposing the product to varying conditions that age latex.
- On November 7, FDA approved Fortovase, a new formulation of Invirase (saquinavir) for the treatment of HIV-1.
Last revised January 20, 1998, Office of Special Health Issues, HF-12.