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Verified Clinical Benefit | Infectious Disease Accelerated Approvals (excluding vaccines)

Intelence (etravirine) In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replications and HIV-1 strains resistant to non-nucleloside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agent 1/18/2008 11/24/2009 Isentress (raltegravir) In combination with other antiretroviral agents, for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretorviral agents 10/12/2007 1/29/2009 Selzentry (maraviroc) For the treatment of patients with CCR5-tropic HIV-1 8/6/2007 11/25/2008 Prezista (darunavir) For the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor 6/23/2006 10/21/2008 Aptivus (tipranavir) Co-administered with 200 mg of ritonavir for combination antiretroviral treatment of HIV-1 infected adult patients with evidence of viral replication, who are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors 6/22/2005 10/4/2007 Truvada (tenofovir disoproxil fumarate; emtricitabine) In combination with other antiretroviral agents for the treatment of HIV infection in adults 8/2/2004 3/8/2006 Fuzeon (enfuvirtide) Iin combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy 3/13/2003 10/15/2004 Viread (tenofovir disoproxil fumarate) For the treatment of HIV-1 infection in adults 10/26/2001 3/8/2006 Trizivir (abacavir sulfate; lamivudine; zidovudine) Alone or in combination with other antiretroviral agents for the treatment of HIV-1 infection 11/14/2000 5/13/2005 Kaletra (capsules; lopinavir: ritonavir) In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients age six months or older 9/15/2000 11/27/2002 Kaletra (oral solution; lopinavir: ritonavir) In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients age six months or older 9/15/2000 11/27/2002 Cipro (ciprofloxacin) For the treatment of inhalational anthrax (post-exposure) 8/30/2000 1/7/2005 Agenerase (capsules; amprenavir) In combination with other antiretroviral agents, for the treatment of HIV-1 infection 4/15/1999 5/11/2001 Agenerase (oral solution; amprenavir) In combination with other antiretroviral agents, for the treatment of HIV-1 infection 4/15/1999 5/11/2001 Ziagen  (tablets; abacavir sulfate) In combination with other antiretroviral agents, for the treatment of HIV-1 infection 12/17/1998 4/15/2004 Ziagen (oral solution; abacavir sulfate) In combination with other antiretroviral agents, for the treatment of HIV-1 infection 12/17/1998 4/15/2004 Sustiva (efavirenz) In combination with other antiretroviral agents, for the treatment of HIV-1 infection 9/17/1998 2/9/2000 Viramune (nevirapine) Provides for an oral suspension in combination with other antiretroviral agents for the treatment of HIV-1 infection 9/11/1998 3/27/2002 Viramune (nevirapine) Iin combination with other antiretroviral agents for treatment of HIV-1 infection 9/11/1998 3/27/2002 Priftin (rifapentine) For the treatment of pulmonary tuberculosis 6/22/1998 6/1/2009 Rescriptor (delavirdine mesylate) for the treatment of HIV-1 infection in combination with appropriate antiretroviral agents when therapy is warranted 4/4/1997 5/16/2001 Viracept  (oral powder; nelfinavir mesylate) For the treatment of HIV infection when therapy is warranted 3/14/1997 5/17/2000 Viracept (tablets; nelfinavir mesylate) For the treatment of HIV infection when antiretroviral therapy is warranted 3/14/1997 5/17/2000 Serostim (somatropin) For the treatment of aids wasting and cachexia 8/23/1996 8/29/2003 Viramune (nevirapine) In combination with nucleoside analogues for the treatment of HIV-1 infected adults who have expreienced clinical and/or immunological deterioration 6/21/1996 3/27/2002 Crixivan (indinavir sulfate) For the treatment of HIV-1 infection in adults when therapy is warranted 3/13/1996 2/6/1998 Norvir (oral solution; ritonavir) In combination with nucleoside analogs or as monotherpy for the treatment of HIV infection when therapy is warranted 3/1/1996 5/26/1999 Invirase (saquinavir mesylate) In combination with nucleoside analogs for the treatment of advanced HIV infection in selected patients 12/6/1995 9/27/1996 Epivir (lamivudine) In combination with retrovir (zidovudine) for the treatment of HIV infection when therapy is warranted based on clinical and/or immunological evidence of disease progression 11/17/1995 4/11/1997 Zerit (stavudine) For the treatment of adult patients with advanced HIV infection who are intolerant of approved therapies with proven clinical benefit or who have experienced significant clinical or immunological deterioration while receiving these therapies or for whom such therapies are contraindicated 6/24/1994 12/21/1995 Biaxin (clarithromycin) For the treatment of disseminated mycobacterial infections due to mycobacterium avium and mycobacterium intracellulare 12/23/1993 5/24/2002 Hivid (zalcitabine) In combination with zidovudine for the treatment of adult patients with advanced HIV infection (cd4 cell counts < 300 cells/mm3) who have demonstrated significant clinical or immunologic deterioration 6/19/1992 6/26/1996

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