Approved Therapies for HIV/AIDS or AIDS-related Conditions
FDA has approved 33 products to treat HIV/AIDS. Eleven drugs are to treat HIV infection and 22 are to treat HIV/AIDS-related illnesses:
Zidovudine (AZT) (Retrovir/Glaxo Wellcome) approved March, 1987 for the treatment of AIDS. Approved September 1989, in syrup formulation. Approved February 1990, in intravenous dosage form. Dosage/indication labeling revisions: decreased recommended dose (January 1990), added indication for use in early symptomatic HIV disease and in asymptomatic HIV infection where there is evidence of impaired immunity(March 1990), added indication for use in children 3 months to 12 years (May 1990), added indication for use in preventing transmission of HIV from HIV-infected pregnant women to their babies (August 1994)
Human Interferon alpha (Intron A/Schering-Plough and Roferon-A/Hoffmann-La Roche) licensed November 1988, for the treatment of Kaposi's sarcoma.
Aerosolized pentamidine (NebuPent/Fujisawa) approved June 1989, for the prevention of Pneumocystis carinii pneumonia in immunocompromised patients.
Ganciclovir (intravenous)(Cytovene/Syntex) approved June 1989, for the treatment of cytomegalovirus retinitis. Oral ganciclovir approved December 1994 for the treatment of CMV retinitis in immunocompromised individuals. Oral ganciclovir approved on October 27, 1995 as a prophylactic treatment for the prevention of HIV-related cytomegalovirus (CMV)disease.
Vitrasert (Chiron Vision)sterile intravitreal implant with Cytovene was approved March 1996 for the treatment of cytomegalovirus retinitis.
Fluconazole (oral and injectable) (Diflucan/Pfizer),approved January 1990, for use in the treatment of candidiasis and cryptococcal meningitis. Added indication for treatment of pediatric patients with cryptococcal meningitis and candidal infections (November 1994).
Erythropoietin (Epogen/Amgen and Procrit/Ortho Biotech), licensed December 1990, for the treatment of zidovudine-related anemia.
Foscarnet (Foscavir/Astra Pharmaceutical) approved September 1991, for use in the treatment of cytomegalovirus retinitis. Approved on June 1995 for the treatment of acyclovir-resistant herpes simplex virus.
ddI (didanosine), (Videx/Bristol Myers-Squibb) approved October 1991, for the treatment of adult and pediatric patients (over 6 months of age) with advanced HIV infection who are intolerant of zidovudine therapy or who have demonstrated significant clinical or immunologic deterioration during zidovudine therapy. Dosage recommendations decreased, September 1992.
ddC (zalcitabine), (Hivid/Hoffmann-La Roche) approved June 1992, 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. Approved in August 1994 for monotherapy treatment for HIV-infection in adults.
Itraconazole, (Sporanox/Janssen Pharmaceutica) approved September 1992, for the treatment of blastomycosis and histoplasmosis in immunocompromised and non-immunocompromised patients. Approved in March 1994 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.
Atovaquone, (Mepron/Glaxo Wellcome) approved November 1992, for the treatment of mild to moderate PCP in patients who are intolerant to standard therapy. Approved in February 1995, for the treatment of mild to moderate PCP in patients who are intolerant of trimethoprim-sulfamethoxazole(TMP-SMX).
Dronabinol, (Marinol/Roxane Laboratories) approved December 1992, (new indication) for anorexia and weight loss associated with AIDS.
Rifabutin, (Mycobutin/Adria Laboratories) approved December 1992, for the prophylaxis of Mycobacterium avium complex, a severe infection that often afflicts AIDS patients.
Megestrol acetate, (Megace/Mead Johnson Laboratories) approved September 1993, (new indication), for anorexia, cachexia, or an unexplained weight loss in patients with AIDS.
Trimetrexate glucuronate, (Neutrexin/U.S. Bioscience) approved December 1993, for the treatment of moderate to severe Pneumocystis carinii pneumonia. (Must be administered concurrently with leucovorin [folinic acid]).
Clarithromycin, (Biaxin/Abbott Labs) approved December 1993, (new indication) for the treatment of disseminated mycobacterial infections due to Mycobacterium avium and Mycobacterium intracellular (Mycobacterium avium complex--MAC). Approved on October 1995 for the prevention of Mycobacterium avium complex (MAC).
Immune Globulin Intravenous (Human)/IGIV (Gamimune/Bayer Pharmaceutical Division), licensed December 1993, (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.
Trimethoprim/Sulfamethoxazole, (Bactrim/Hoffmann-La Roche and Septra/Glaxo Wellcome) approved January 1994, (new indication) for the prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia.
Stavudine/d4T (Zerit/Bristol Myers-Squibb) received accelerated approval in June 1994 for treatment of adults with HIV infection who no longer respond to or are intolerant of other anti-viral drugs. Approved in December 1995 for full marketing approval.
Doxorubicin HCL Liposome injection (Doxil/Sequus Pharmaceuticals, Inc) approved November 1995 for the treatment of Kaposi's Sarcoma.
Lamivudine/3TC (Epivir/Glaxo Wellcome) received accelerated approval in November 1995 for use in combination with Retrovir (zidovudine, AZT)in treating AIDS and HIV infection.
Amphotericin B lipid complex (Abelcet/The Liposome Company) approved November 1995 for the treatment of aspergillosis.
Saquinavir (Invirase/Hoffmann-La Roche) received accelerated approval in December 1995 for use in combination with other nucleoside analogue medications for the treatment of advanced HIV disease.
Ritonavir (Norvir/Abbott Laboratories) received full approval in March 1996 for use alone or in combination with nucleoside analogue medications in people with advanced HIV disease. Ritonavir also received accelerated approval for less advanced HIV disease.
Indinavir (Crixivan/Merck & Co. Inc.) received accelerated approval in March 1996 for use alone or in combination with nucleoside analogue medication in people with HIV or AIDS.
Daunorubicin Citrate Liposome injection (DaunoXome/Nexstar, Inc.) received full approval in April 1996 for first line cytotoxic treatment of advanced, HIV-associated Kaposi's sarcoma (KS).
Azithromycin (Zithromax/Pfizer Inc.) received full approval in June 1996 for preventing or delaying the onset of infection with mycobacterium avium complex (MAC).
Nevirapine (Viramune/Boehringer Ingelheim Pharmaceuticals, Inc/Roxane Laboratories Inc) received accelerated approval in June 1996 for the use in combination with nucleoside analogues to treat adults with HIV infection who have experienced clinical and/or immunological deterioration. Nevirapine is the first approval in a new class of drugs called non-nucleoside reverse transcriptase inhibitors.
Cidofovir (Vistide/Gilead Sciences Inc.) received full approval in June 1996 as an intravenous treatment for AIDS-related CMV retinitis, a potentially severe eye infection that can lead to blindness.
Somatropin rDNA origin for injection (Serostim/Serono Laboratories) received accelerated approval in August 1996 for the treatment of AIDS wasting and cachexia.
Nelfinavir (Viracept/Agouron Pharmaceuticals) received accelerated approval in March 1997 for the treatment of HIV infection in both adults and children.
Delavirdine (Rescriptor/Pharmacia & Upjohn) received accelerated approval in April 1997 for use in combnation with appropriate anti-HIV medications to treat patients with HIV infection when treatment is warranted.