For Consumers

HIV/AIDS Historical Time Line 2010 - 2011

 2010| 2011  


The decade ended with the following notable activities in the area of HIV/AIDS at FDA during 2010:

New Drug Approvals

  • Egrifta (tesamorelin) to treat lipodystrophy
  • New tablet formulation of Norvir (ritonavir)

Generic Drug Approvals

  • Generic zidovudine injection, 10 mg/mL
  • generic didanosine delayed-release capsules, 125 mg, 200 mg, 250 mg, and 400 mg

Tenative Approvals for PEPFAR purchase eligibility

  • Abacavir sulfate tablets, 60 mg
  • Abacavir Sulfate Tablets, 300 mg (2 tentative approvals)
  • Lamivudine, nevirapine, and stavudine fixed dose combination tablets, 150 mg/200 mg/30 mg (2 tenative approvals of this formulation)
  • Atazanavir sulfate capsules, 300 mg
  • Lamivudine and stavudine Fixed Dose Combination tablets 150mg/30mg (2 tentative approvals)
  • Fixed dose combination lamivudine, nevirapine, and zidovudine tablets for Oral Solution, 30 mg/50 mg/60 mg
  • Tenofovir disoproxil fumarate tablets, 300 mg
  • Nevirapine tablets for oral suspension, 50 mg
  • Efavirenz cross-scored tablets, 200 mg

Changes in labeling:

  • New dosage for Intelence (etravirine)
  • Prezista (darunavir) once daily dosing for certain treatment experienced adults
  • Zerit capsules and Zerit for oral solution changes in Dosage and Administration, Warnings and Precautions, Adverse Reaction sections
  • Invirase (saquinavir) label update with risk information about abnormal heart rhythms
  • Isentress (raltegravir potassium) label update to reflect 96 week safety/efficacy results in treatment-naive and treatment-experienced patients
  • Selzentry (maraviroc) labeling changes for patients with renal impairment
  • Kaletra (lopinavir/ritonavir) Tablets and Oral Solution once daily dosing regimen in certain adult patients
  • New label information affecting all approved protease inhibitors for treatment of HIV re: concomitant drug use and interactions
  • Sustiva (efavirenz) capsules and tablets labeling upates
  • Expanded indication for Viread, to include the treatment of patients 12 to less than 18 years of age
  • Intelence (etravirine) label revised to include new drug-drug interaction information
  • Kaletra (lopinavir/ritonavir) package insert revision re: drug-drug interaction information
  • Videx EC/Videx label change reflecting potential for serious liver disorder
  • Prezista (darunavir) labeling change reflecting 96 week study data
  • Atripla label update reflecting new efficacy, safety and resistance data in treatment experienced patients

Aprpoval of new HIV testing assays:

  • Rapid INSTI HIV-1 60 second Antibody Test
  • Fourth Generation HIV Diagnostic Test Approved, permitting earlier detection of infection

Guidance for Industry:

  • New Guidance for Industry: Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination
  • Draft guidance re: development of antivirals for Chronic Hepatitis C, including coinfection with HIV

Advisory Committee Meetings:

  • HHS Blood Safety and Availability Advisory Committee meeting re: policy on deferral of donors with high-risk exposure to HIV
  • FDA Endocrinologic and Metabolic Drugs Advisory Committee re: application for Egrifta (tesamorelin acetate) to treat lipodystrophy  



New Drug Approvals:

  • Complera (emtricitabine/rilpivirine/tenofovir DF) fixed dose combination tablets, 200mg/25mg/300mg , a new complete regimen for treatment naïve patients
  • Edurant (rilpivirine) 25 mg tablets, a new NNRTI for treatment naïve adult patients
  • Viramune XR (nevirapine) tablet, 400 mg, a new extended release formulation NNRTI for use in combination with other antiretrovirals

New Drug Tentative Approvals for PEPFAR purchase eligibility:

  • Notable this year are the multiple combination fixed-dose drugs that allow for improved dosing schedules and the solutions/suspension drug formulations that offer additional options for patients who have difficulty swallowing tablets.
  • lamivudine and zidovudine fixed-dose combination tablets, 30 mg/60 mg
  • lamivudine and tenofovir DF fixed-dose combination tablets, 300mg/300mg
  • tenofovir disoproxil fumarate tablets, 300 mg
  • emtricitabine capsules, 200 mg
  • abacavir sulfate oral solution, 20 mg (base)/mL
  • abacavir sulfate scored tablets for oral suspension, 60 mg
  • abacavir sulfate and lamivudine fixed-dose combination scored tablets, 60 mg/30 mg, for pediatric dosing
  • lamivudine and tenofovir DF fixed-dose combination tablets, 300 mg/300 mg, co-packaged with nevirapine tablets, 200 mg

New Diagnostic Test Approvals:

  • The GS HIV Combo Ag/Ab EIA, the second “Fourth Generation" HIV diagnostic assay which allows for the detection of HIV p24 antigen and antibodies to HIV-1 groups M and O as well as HIV-2 

Generic Drug Approvals:

  • lamivudine and zidovudine fixed dose combination tablets, 150 mg/300 mg
  • zidovudine water-dispersible tablets, 100 mg, intended for use in pediatrics and all patients unable to swallow tablets

    Labeling Changes:

  • Reyataz (atazanavir) added dosing recommendations during pregnancy and postpartum period
  • Viracept (nelfinavir) added drug-drug interaction information between nelfinavir and wafarin
  • Kaletra (lopinavir/ritonavir) oral solution product label related to toxicity in preterm neonates secondary to adverse events related lopinavir and/or the inactive ingredients propylene glycol and ethanol
  • Update to Fuzeon (efuvirtide) label regarding the increased of bacterial pneumonia

Other notable events:

  • Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents released updated Adult HIV Treatment Guidelines
  • The 30th Anniversary of the initial report in the Centers for Disease Control and Prevention’s MMRW of what would later become known as HIV/AIDS



Page Last Updated: 08/08/2014
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