Verified Clinical Benefit | Infectious Disease Accelerated Approvals (excluding vaccines)
This listing includes accelerated approvals (AAs) for infectious disease indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication.
Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. See Postmarket Requirements and Commitments for the status of specific requirements.
Visit Accelerated Approvals for listings of ongoing, verified clinical benefit, and withdrawn infectious diseases and non-malignant hematological, neurological, and other disorder indications accelerated approvals.
Indications may remain on this page until FDA updates product labeling or publishes a Federal Register notice regarding a change in status.
Total approval time was adjusted based on management decision. This is a legacy practice and is no longer exercised.
| Drug Name | Accelerated Approval Indication | Accelerated Approval Date | Traditional Approval Date |
|---|---|---|---|
| Sirturo (bedaquiline) | For the treatment of pulmonary multi-drug resistant tuberculosis as part of combination therapy, in adult and pediatric patients (12 to less than 18 years of age and weighing at least 30 kg) to include patients ≥ 5 to <12 years of age and weighing at least 15 kg | 5/27/2020 | 6/21/2024 |
| Sirturo (bedaquiline) | As part of combination therapy for the treatment of adult and pediatric patients (12 to less than 18 years of age and weighing at least 30kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB) | 8/9/2019 | 6/21/2024 |
| Sirturo (bedaquiline) | For the treatment of, as combination therapy, adults (≥ 18 years) with pulmonary multi-drug resistant tuberculosis (MDR-TB) | 12/28/2012 | 6/21/2024 |
| Lampit (nifurtimox) | For the treatment of Chagas disease in pediatric patients birth to less than 18 years of age and weighing at least 2.5 kg | 8/6/2020 | 6/2/20231 |
| 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 |
- 1The postmarketing requirement for Lampit was released as it was no longer needed because the seroconversion data from the CHICO SECURE study confirmed clinical benefit.