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Approved Drugs for HIV/AIDS or AIDS-related Conditions.

July 6, 1999

* Abacavir (Ziagen), Glaxo Wellcome

Approved December 17, 1998 to treat HIV-1 in adults and children. Accelerated Approval

Approval Letter Approved Labeling

* Agenerase (Amprenavir) Glaxo Wellcome

Approved April 15, 1999 to treat HIV-1 in adults and children. Accelerated Approval

* Alitretinoin (Panretin) gel 0.1%, Ligand Pharmaceuticals

Approved on February 2, 1999 for the topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma.

Approval Letter Approved Labeling

* Amphotericin B Liquid Complex (Abelcet, ABLC, Ambisome), The Liposome Company

Approved November 20, 1995 for the treatment of aspergillosis

* Atovaquone (Mepron, 566C80), Glaxo Wellcome

Approved November 25, 1992 for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in patients who are intolerant to Bactrim or Septra.

Approved February 8, 1995 for the treatment of mild to moderate PCP in patients who are intolerant of Trimethoprim-Sulfamethoxazole (TMP-SMX)

Approved January 5, 1999 for the prevention of PCP. Approval Letter Approved Labeling

* Azithromycin (Zithromax), Pfizer, Inc.

Approved June 14, 1996 for the prevention of Mycobacterium avium complex in persons with advanced HIV infection.

* Cidofovir (Vistide, HPMPC), Gilead Sciences, Inc.

Approved June 27, 1996 for the treatment of AIDS-related cytomegalovirus retinitis.

* Clarithromycin (Biaxin, Klacid), Abbott Laboratories

Approved December 23, 1993 for the treatment of disseminated mycobacterial infections due to Mycobacterium avium-intracellulare complex (MAC). Accelerated Approval

Approved October 12, 1995 for prophylaxis of disseminated MAC in patients with advanced HIV infection.

* Daunorubicin-liposomal (DaunoXome), Nexstar

Approved April 8, 1996 for the treatment of advanced HIV-related Kaposi's sarcoma.

* Delavirdine mesylate (DLV, Rescriptor), Pharmacia & Upjohn

Approved April 4, 1997 for use in combination with appropriate antiretrovirals when therapy is warranted for treatment of HIV infection. Accelerated Approval

* Didanosine (ddI, Dideoxyinosine, Videx), Bristol Myers-Squibb

Approved October 9, 1991 for treatment of adult and pediatric patients with advanced HIV who are intolerant to or deteriorating on AZT.

September 1992 expanded indication and dosage recommendations reduced. Approved July 17, 1996 for treatment of HIV infection when antiretroviral therapy is warranted.

* Doxorubicin hydrochloride-liposomal (Doxil), Sequus Pharmaceuticals, Inc.

Approved November 17, 1995 for the treatment of Kaposi's sarcoma in AIDS patients who are intolerant to or have disease progression on prior combination chemotherapy.

* Dronabinol (Marinol), Roxane Laboratories

approved December 23, 1992 for the treatment of anorexia associated with weight loss in patients with AIDS.

* Efavirenz (Sustiva), DuPont Pharmaceuticals

Approved September 17, 1998 for the treatment of HIV-1 infection, in combination with other antiretroviral agent(s). New Drug Application Page

* Erythropoietin (EPO, Epogen, Procrit), Amgen

Approved December 31, 1990 for the treatment of anemia related to AZT therapy in HIV infection.

* Famciclovir (Famvir), SmithKline Beecham

Approved June 12, 1998 for the treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients.

* Fluconazole (Diflucan), Pfizer, Inc.

Approved January 29, 1990 for the treatment of oropharyngeal and esophageal candidiasis and for the treatment of cryptococcal meningitis.

Approved November 13, 1994 for the treatment of pediatric patients with cryptococcal meningitis and candida infections.

* Fomivirsen Sodium Injection (Vitravene introvitreal injectable), Isis Pharmaceuticals

Approved on August 26, 1998 for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) who are intolerant of or have a contraindication to other treatment(s) for CMV retinitis or who were insufficiently responsive to previous treatment(s) for CMV retinitis. Approval Letter, Labeling and Consumer Information

* Foscarnet (Foscavir), Astra Pharmaceuticals

Approved September 27, 1991 for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS.

Approved June 16, 1995 for the treatment of acyclovir-resistant mucocutaneous herpes simplex virus infections in immunocompromised patients.

Approved February 1997 for combination therapy with foscavir and ganciclovir of patients who have relapsed after monotherapy with either drug.

* Ganciclovir (IV, Oral)(Cytovene, DHPG), Syntex

Approved June 23, 1989 (IV) for treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients.

Approved December 22, 1994 (oral) for maintenance therapy for CMV retinitis in some patients.

Approved October 31, 1995 (oral) for prophylaxis of CMV disease.

* Ganciclovir (Implant) (Vitrasert), Chiron Corporation

Approved March 5, 1996 for the treatment of cytomegalovirus retinitis in patients with AIDS.

* Immune globulin (IV) (Gamimune N, Gamma Globulin, IGIV), Bayer Pharmaceutical Division

Approved December 27, 1993 for prevention of bacterial infections in pediatric HIV infection.

* Indinavir sulfate (Crixivan, IDV, MK-639), Merck & Co.

Approved March 14, 1996 for use alone or in combination with nucleoside analogues for the treatment of HIV infection in adults. Accelerated Approval

Approved December 17, 1998 new 333 mg capsule formulation

* Interferon Alfa-2a (Roferon-A), Schering-Plough Approved November 21, 1988 for the treatment of AIDS-related Kaposi's sarcoma in selected patients.

* Interferon Alfa2b (Intron-A), Hoffmann-La Roche

Approved November 21, 1988 for the treatment of adult AIDS-related Kaposi's sarcoma.

Approved February 25, 1991 for the treatment of chronic Non-A, Non-B hepatitis.

* Itraconazole (Sporanox), Janssen Pharmaceutical

Approved September 11, 1992 for the treatment of histoplasmosis, blastomycosis, and aspergillosis in immunocompromized and non-immunocompromised patients.

Approved March 29, 1994 for the treatment of pulmonary and extra pulmonary aspergillosis in patients who are intolerant of or refractory to amphotericin B.

Approved February 1997 (oral solution) for the treatment of oropharyngeal and esophageal candidiasis..

* Lamivudine (Epivir, 3TC), Glaxo Wellcome

Approved November 17, 1995 for combination use with AZT as a treatment option for HIV infection in adults and pediatrics patients greater than or equal to 3 months old. Accelerated Approval

* Lamivudine/Zidovudine (Combivir), Glaxo Wellcome

Approved September 27, 1997 for the treatment of HIV infection in adults and adolescents greater than or equal to 12 years old.

* Megestrol acetate (Megace, Ovarian), Mead Johnson Laboratories

Approved September 10, 1993 for the treatment of anorexia, cachexia, or unexplained, significant weight loss in patients with AIDS.

* Nelfinavir mesylate (NFV, Viracept), Agouron Pharmaceuticals Approved March 14, 1997 for the treatment of HIV infection when antiretroviral therapy is warranted in adults and pediatrics greater than or equal to 2 years old.

Accelerated Approval

* Nevirapine (Viramune, BI-RG-587), Boehringer Ingelheim Pharmaceuticals, Inc.

Approved June 24, 1996 for use in combination with nucleoside analogues for the treatment of HIV-infected adults experiencing clinical and/or immunologic deterioration. Accelerated Approval

* Paclitaxel (Taxol), Bristol Myers-Squibb Pharmaceutical Research Institute

Approved August 4, 1997 for the second-line treatment of AIDS-related Kaposi's sarcoma.

* Pentamidine (aerosolized) (NebuPent), Fujisawa

Approved June 15, 1989 for the prevention of Pneumocystis carinii pneumonia.

* Rifabutin (Ansamycin, Mycobutin), Adria Laboratories

Approved December 23, 1992 for the prevention of Mycobacterium avium complex in patients with advanced HIV.

* Ritonavir (Norvir, ABT-538), Abbott Laboratories

Approved March 1, 1996 for use alone or in combination with nucleoside analogues for the treatment of HIV infection. Accelerated Approval

Approved March 14, 1997 for the use of alone or in combination with nucleoside analogues for the treatment of HIV infection in selected patients.

Approved June 29, 1999 soft gelatin, 100 mg capsule

* Saquinavir mesylate (Fortovase [soft gel capsule], Invirase [hard gel capsule], SQV), Hoffmann-La Roche

Approved December 7, 1995 for combination use with nucleoside analogues for the treatment of advanced HIV infection in selected patients. Accelerated Approval

* Somatropin rDNA (Serostim), Serono Laboratories

Approved August 23, 1996 for the treatment of AIDS-wasting and cachexia.

Accelerated Approval

* Stavudine (d4T, Zerit), Bristol Myers-Squibb

Approved June 17, 1994 for the treatment of adults with advanced HIV infection who are intolerant to or deteriorating on approved therapies. Accelerated Approval and Parallel Track

Approved January 4, 1996 for the treatment of adults with HIV infection who have undergone prolonged treatment with AZT.

Approved September 6, 1996 for the treatment of pediatrics with HIV infection who have undergone prolonged prior AZT therapy.

* Sulfamethoxazole/Trimethoprim, Glaxo Wellcome

(Bactrim when combined with Trimethoprim; Septra when combined with Trimethoprim; SMX)

Approved June 23,1981 for the treatment of Pneumocystis carinii pneumonia (PCP)

Approved January 7,1994 for the prevention of PCP.

* Trimethoprim/Sulfamethoxazole, Hoffmann La-Roche

(Bactrim when combined with Sulfamethoxazole; Septra when combined with Sulfamethoxazole; SMX)

Approved June 23, 1981 for the treatment of Pneumocystis carinii pneumonia (PCP)

Approved January 7, 1994 for the prevention of PCP.

* Trimetrexate glucuronate (with Leucovorin)(Neutrexin, TMTX), U.S. Bioscience

Approved December 17, 1993 for the treatment of moderate to severe

Pneumocystis carinii pneumonia when intolerant or refractory to TMP/SMX or when TMP/SMX is contraindicated.

* Zalcitabine (ddC, Dideoxycytidine, HIVID), Hoffmann-La Roche

Approved June 19, 1992 for combination use with AZT for the treatment of selected patients with advanced HIV disease. This approval was based on the accelerated approval regulations.

Approved August 5, 1994 for monotherapy treatment of advanced HIV for those aged more than 13 years who are intolerant to or have disease progression on AZT.

* Zidovudine (Azidothymidine, AZT, Retrovir, ZDV), Glaxo Wellcome

Approved March 19, 1987 for the treatment of adult AIDS, or symptomatic HIV and CD4 less than or equal to 200

September 28, 1989 in syrup formulation

January 1990, decreased recommended dosage

February 2,1990 in intravenous dosage form

March 1990 for use in early symptomatic HIV disease and in asymptomatic HIV infection where there is evidence of impaired immunity.

May 3, 1990 for the treatment of pediatric HIV infection (ages 3 months to 12 years)

August 8, 1994 for the prevention of perinatal transmission in HIV+ pregnant women between 14 and 34 weeks gestation and for newborns of HIV+ mothers.

Last revised July 6, 1999 Office of Special Health Issues, HF-12 E-mail: oshi@oc.fda.gov Office of International and Constituent Relations

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Publication:Pamphlet by: Food and Drug Administration
Article Type:Pamphlet
Geographic Code:1USA
Date:Jul 6, 1999
Words:1520
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