For Consumers
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What's New at FDA in HIV/AIDS
Late breaking information, as well as an archival record of updates on safety and regulatory issues related to HIV/AIDS, dating from 2002 to present. Information includes
- product approvals
- significant labeling changes
- safety warnings
- notices of upcoming public meetings
- notices about proposed regulatory guidances
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Archive of older postings to the FDA/HIV e-mail list, from 2002 - 2005
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2012
- 09/24/2012
Tentative approval of Lamivudine, Nevirapine and Zidovudine Fixed Dose Combination Scored Tablets for Oral Suspension - 08/27/2012
Approval of new fixed dose combination, Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) - 07/23/2012
More than 150 antiretroviral drugs available through PEPFAR for worldwide HIV/AIDS relief - 07/16/2012
Truvada approved to reduce the risk of sexually transmitted HIV in people who are not infected with the virus - 07/02/2012
Tentative approval of lopinavir and ritonavir Oral Solution, 80 mg/20 mg per mL - 06/26/2012
Tenative approval for efavirenz tablets, 600 mg - 06/22/2012
Tenative approval of efavirenz tablets, 600 mg - 06/19/2012
Approval of generic abacavir tablets, 300 mg - 06/07/2012
Development of Topical Microbicides: New page on the FDA.gov site - 06/01/2012
Prezista (darunavir) label update - 06/01/2012
Two tentative approvals of lamivudine for PEPFAR - 05/25/2012
Tentative approval of lopinavir and ritonavir tablets 200 mg/50 mg - 05/24/2012
Approval of generic nevirapine formulations - 05/23/2012
Abacavir induces loading of novel self-peptides into HLA-BM57:01: an autoimmune model for HLA-associated drug hypersensitivity - 05/23/2012
Generic approval of lamivudine and zidovudine tablets USP, 150 mg/300 mg - 05/23/2012
New approval of generic formulation of lamivudine and zidovudine Tablets, 150 mg/300 mg - 05/12/2012
Tentative approval of nevirapine tablets 200 mg - 05/01/2012
Tentative approval of nevirapine tablets for oral suspension, 50 mg and 100 mg for pediatric use - 04/30/2012
New pediatric Lexiva dosing regimen for patients from at least 4 weeks to less than 6 years of age - 04/19/2012
Isentress label update includes 156-week safety and efficacy data - 04/05/2012
FDA Blood Products Advisory Committee Mtg, May 15-16, 2012, In-Home HIV Test - 03/29/2012
Isentress (raltegravir) label update - 03/28/2012
Updated HHS Adult and Adolescent Antiretroviral Treatment Guidelines available - 03/26/2012
May 11, 2012 FDA advisory committee meeting: fixed-dose combination tablet of elvitegravir/cobicistat/emtricitabine/ tenofovir disoproxil fumarate - 03/26/2012
Intelence (etravirine): pediatric dosing recommendations and new scored 25 mg tablet for pediatric dosing - 03/16/2012
May 10, 2012 FDA advisory committee meeting: Truvada for Pre-Exposure Prophylaxis (PrEP) - 03/01/2012
Important information about interactions between certain HIV drugs and cholesterol-lowering statin drugs - 02/10/2012
Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs - Drug Interactions - 02/08/2012
Tenative approval of lamivudine, nevirapine, and zidovudine fixed dose combination / PEPFAR - 01/31/2012 Tentative approval of abacavir sulfate and lamivudine tablets 60mg/30mg for pediatric patients
- 01/19/2012
Viread: new formulation, and pediatric dosing update - 01/06/2012
Sustiva labeling update / dosing adjustment with rifampin
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2011
2011
- 12/23/2011
Tentative approval of emtricitabine/tenofovir disoproxyl fumarate tablets for PEPFAR - 12/21/2011
Isentress (raltegravir): pediatric dosing recommendations and 2 chewable tablet formulations for pediatric dosing - 12/19/2011
Updated information about Prezista (darunavir): oral suspension and labeling changes - 12/07/2011
Safety revisions to Norvir (ritonavir) tablets, capsules and oral solution labeling - 12/01/2011
Statement from FDA Commissioner Margaret Hamburg, M.D. on World AIDS Day 2011 - 11/18/2011
Tentative approval of lamivudine/nevirapine/zidovudine 150 /200 /300 mg fixed-dose combination - 11/18/2011
Tentative approval of atazanavir sulfate and ritonavir fixed dose combination tablets - 11/09/2011
Disposal of needles and other medical sharps - 11/02/2011
Isentress (raltegravir) package insert updated - 10/20/2011
Prezista label update includes 192-week safety, resistance and efficacy data - 10/14/2011
Revised: Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents - 09/22/2011
Tentative approval of lamivudine and zidovudine fixed dose combination scored tablets, 30 mg/60 mg - 09/08/2011
Tentative approval of fixed dose lamivudine/tenofovir + nevirapine for PEPFAR - 08/10/2011 Approval of Complera: emtricitabine/rilpivirine/tenofovir DF fixed dose combination
- 07/22/2011
Approval of 2nd Fourth Generation HIV Diagnostic Test for earlier detection of infection - 06/05/2011
Commemorating thirty years - 05/25/2011
Tentative approval for tenofovir disoproxil fumarate tablets, 300 mg - 05/25/2011
Approval of generic formulation of lamivudine and zidovudine tablets, 150 mg/300 mg - 05/20/2011
Approval of Edurant (rilpivirine) a new NNRTI) for the treatment of HIV in treatment naive patients - 05/12/2011
Tentative approval of abacavir sulfate and lamivudine fixed-dose combination tablet for pediatric dosing - 04/29/2011
Update to Fuzeon (enfuvirtide) label regarding incidence of bacterial pneumonia - 03/29/2011
Tentative approval of emtricitabine capsules, 200 mg - 03/28/2011
Approval of Viramune XR (nevirapine) 400 mg extended release tablet - 03/09/2011
Tentative approval for Lamivudine and Tenofovir DF Fixed Dose Combination Tablets, 300 mg/300 mg - 03/04/2011
Tentative approval for abacavir sulfate scored tablets for oral suspension, 60 mg - 03/01/2011
Safety Review update of Abacavir: no statistically significant association seen between myocardial infarction and ABC - 02/24/2011
Kaletra (lopinavir/ritonavir) Oral Solution label changes related to toxicity in preterm neonates - 02/24/2011
Viracept (nelfinavir) Label change reflects drug-drug interaction information with warfarin - 02/24/2011
Approval of zidovudine water-dispersible tablets, 100 mg for pediatrics/adults unable to swallow tablets - 02/17/2011
Tentative approval of abacavir sulfate Oral Solution, 20 mg/mL - 02/08/2011
Important information about alcohol prep pads packaged with Fuzeon and certain other injection products - 02/04/2011
Reyataz (atazanavir) label revised, adding dosing recommendations for pregnancy and postpartum period - 01/10/2011
Revised Adult HIV Treatment Guidelines are available - 01/07/2011
Tentative approval of lamivudine and tenofovir DF 300 mg/300 mg fixed-dose combination - 01/06/2011
Tentative approval of lamivudine and zidovudine tablets, 30 mg/60 mg fixed-dose combination
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2010
- 12/23/2010
New Intelence (etravirine) dosage approved - 12/16/2010
New Guidance for Industry: Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination - 12/13/2010
New labeling approved for Prezista (darunavir) - 12/10/2010
New labeling for Zerit capsules and Zerit for oral solution - 12/01/2010
Approval of rapid INSTI[TM] HIV-1 Antibody Test - 11/30/2010
Tentative approval of abacavir sulfate tablets, 60 mg - 11/10/2010
Approval of Egrifta (tesamorelin) to treat lipodystrophy - 10/21/2010 Update to Invirase (saquinavir) label with risk information about abnormal heart rhythms
- 09/30/2010
Tenative approval of Abacavir Sulfate Tablets, 300 mg - 09/14/2010
Availability of draft guidance re: development of antivirals for Chronic Hepatitis C, including coinfection with HIV - 09/10/2010
Tentiative approval of lamivudine, nevirapine, and stavudine fixed dose combination tablets, 150 mg/200 mg/30 mg - 08/31/2010
Tentiative approval of lamivudine, nevirapine, and stavudine fixed dose combination tablets, 150 mg/200 mg/30 mg - 08/19/2010
Tentative approval of generic atazanavir sulfate capsules, 300 mg - 08/06/2010
-Tentative approval of lamivudine and stavudine Fixed Dose Combination tablets - 07/09/2010
Tentative approval of fixed dose combination lamivudine, nevirapine, and zidovudine tablets for Oral Solution, 30 mg/50 mg/60 mg - 06/30/2010
Isentress (raltegravir potassium) label update reflects 96 week safety/efficacy results in treatment-naive and treatment-experienced patients - 06/18/2010
Fourth Generation HIV Diagnostic Test Approved, permitting earlier detection of infection - 06/01/2010
Selzentry (maraviroc) labeling changes for patients with renal impairment - 05/21/2010
June 10-11, 2010 Advisory Committee meeting re: policy on deferral of donors with high-risk exposure to HIV - 05/18/2010
Tentative approval for lamivudine and stavudine Fixed Dose Combination tablets, 150mg/30mg - 05/14/2010
Tentative approval of abacavir sulfate tablets, 300 mg - 05/07/2010
FDA approval of generic zidovudine injection, 10 mg/mL - 04/28/2010
New Kaletra (lopinavir/ritonavir) Tablets and Oral Solution once daily dosing regimen in certain adult patients - 04/27/2010
New label information affecting all approved protease inhibitors for treatment of HIV - 04/14/2010
Updated label information for Sustiva (efavirenz) - 04/09/2010
Approval of generic Didanosine Delayed-release Capsules, 125 mg, 200 mg, 250 mg, and 400 mg - 04/07/2010
Tentative approval for generic Tenofovir Disoproxil Fumarate Tablets, 300 mg - 03/26/2010
Expanded indication for Viread, to include the treatment of patients 12 to less than 18 years of age - 03/22/2010
FDA Advisory Committee Meeting to Review Egrifta - 03/11/2010
Intelence (etravirine) label revised to include new drug-drug interaction information - 02/24/2010
Tentative approval of nevirapine tablets for oral suspension, 50 mg - 02/23/2010
Ongoing safety review of Invirase (saquinavir) and possible association with abnormal heart rhythms - 02/12/2010
Tenative approval of efavirenz cross-scored tablets, 200 mg - 02/10/2010
FDA approves new tablet formulation of Norvir (ritonavir) - 01/29/2010
Kaletra (lopinavir/ritonavir) package insert revision regarding drug-drug interaction information - 01/29/2010
Videx EC/Videx label change reflects potential for serious liver disorder - 01/28/2010
Prezista (darunavir) labeling changes reflect 96 week study data - 01/08/2010
Atripla label update reflects new efficacy, safety and resistance data in treatment experienced patients
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2009
- January 05, 2010
Tentative approval of lamivudine, nevirapine, and zidovudine fixed dose combination tablets - December 04, 2009
Important information about Lexiva (fosamprenavir calcium) Tablets and Oral Suspension - December 01, 2009
World AIDS Day 2009 - December 01, 2009
Updated Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents available - November 25, 2009
Intelence (etravirine) label updated to reflect dosing data through 48 weeks - November 25, 2009
Tentative approval of generic efavirenz tablets, 50 mg, 100 mg, and 200 mg - November 24, 2009
Expanded indication for Selzentry (maraviroc) - November 24, 2009
Important label update for Norvir (ritonavir) - November 20, 2009
Tentative approval of lopinavir/ritonavir tablets, 200 mg/50 mg - November 10, 2009
New dosing recommendations Retrovir (zidovudine) syrup for HIV-infected infants - November 06, 2009
Tentative approval of lamivudine and tenofovir df fixed dose combination tablets, 300mg/300mg - September 29, 2009
FDA licensing of donor screening test for antibodies to HIV type 1, groups M and O, and HIV type 2 - September 04, 2009
Tentative approval of efavirenz, lamivudine, and tenofovir disoproxil fumarate tablets, 600mg/300mg/300mg - August 31, 2009
New Guidelines for Prevention and Treatment of Opportunistic Infections among HIV-Exposed and HIV-Infected Children - August 26, 2009
New Intelence labeling: severe skin and hypersensitivity reactions - August 13, 2009
Tentative approval of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate - August 12, 2009
New Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs - August 07, 2009
Tentative approval of generic lamivudine tablets, 150 mg and 300 mg - August 04, 2009
Tentative approval of generic efavirenz capsules - July 23, 2009
Approval of zidovudine 60 mg tablets for pediatric dosing - July 23, 2009
Tentative approval of fixed dose combination of lamivudine/zidovudine tablets for pediatric dosing - July 16, 2009
Tentative approval of stavudine/lamivudine/nevirapine fixed dose combination tablets - July 15, 2009
Tentative approval of generic abacavir/lamivudine/zidovudine fixed-dose combination tablet - July 09, 2009
Isentress (raltegravir) indication extended for the treatment of HIV-1 infection in treatment-naïve patients - June 27, 2009
Take the Test / Take Control: National HIV testing Day - June 23, 2009
Tentative approval of lamivudine tablets, 150 mg and 300 mg - June 19, 2009
Important changes to Videx (didanosine) labeling - June 01, 2009
Tentative approval of lamivudine/zidovudine tablets 150 mg/300 mg fixed dose combination - May 18, 2009
Safety concerns prompt label changes and Medication Guide requirement for Testosterone Gel Products - May 12, 2009
Tenative approval of lamivudine/zidovudine fixed dose combination tablets plus nevirapine tablets - May 01, 2009
Important update about Emergency Use Allowance for use of Tamiflu and Relenza - May 01, 2009
Swine Influenza (H1N1) and Adults and Adolescents infectedwith HIV: Considerations for Clinicians - April 30, 2009
Tentative approval, tenofovir disoproxil fumarate tablets, 300 mg - April 21, 2009
Kaletra labeling changes approved - April 06, 2009
Act Against AIDS, a new CDC campaign to raise AIDS awareness - April 06, 2009
Labeling changes for Kaletra reflecting new QT/QTC interval and PR interval prolongation information - April 01, 2009
Tentaive approval of generic nevirapine tablets, 200 mg - March 31, 2009
Tentative approval of abacavir sulfate and lamivudine tablets, 600 mg (base)/300 mg - March 31, 2009
Tentative approval emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg - March 23, 2009
Approval of generic stavudine for oral solution, 1 mg/mL - March 19, 2009
Tentative approval of stavudine and lamivudine fixed dose combination tablets - March 17, 2009
Tentative approval of lamivudine Tablets, 150 mg - March 11, 2009
Tentative approval of lopinavir/ritonavir tablets , 200 mg/50 mg - March 09, 2009
FDA approval of the FC2 Female Condom - March 03, 2009
Tentative approval of stavudine, lamivudine and nevirapine fixed dose combination tablets - February 20, 2009
Important notice for people with impaired immune function about peanut products recalled for Salmonella - February 19, 2009
Tentative approval of tenofovir disoproxil fumarate tablets, 300 mg - February 05, 2009
Traditional approval of Isentress (raltegravir) - March 23, 2009
Approval of generic stavudine for oral solution, 1 mg/mL - January 08, 2009
Approval of generic stavudine capsules 30 mg and 40 mg
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2008
- 12/31/2008
FDA approval of NAT for detection of HIV-2, HIV-1 Groups O and M, and Hepatitis B and C - 12/30/2008
FDA approval of three generic stavudine formulations - 12/19/2008
Ziagen 300 mg scored tablet facilitates pediatric treatment of infection with HIV - 12/19/2008
Tentative approval of abacavir sulfate and lamivudine fixed-dose combination - 12/19/2008
New 75 mg Prezista tablet and corresponding pediatric dosing information approved - 12/14/2008
PEPFAR-related tentative approval of generic efavirenz - 03/16/2012
May 10, 2012 FDA advisory committee meeting: Truvada for Pre-Exposure Prophylaxis (PrEP) - 12/09/2008
FDA Obstetrics and Gynecology Devices Panel meeting to consider FC2 Female Condom - 12/04/2008
Traditional approval and label changes for Selzentry (maraviroc) - 11/16/2008
Final Rule: Latex condom labeling - 11/04/2008
Revised Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents - 10/22/2008
Traditional approval of Prezista (darunavir), a new dosing regimen for treatment-naïve patients, new 400 mg tablets, and revised Pregnancy Category - 10/08/2008
Tentative approval for a generic formulation of lamivudine 150 mg and 300 mg tablets - 10/02/2008
Alternative dosing regimen for Reyataz (atazanavir) for treatment-naïve patients who can take ritonavir - 09/29/2008
Videx EC labeling changes with pediatric dosing information added - 09/25/2008
Approval of generic didanosine delayed release capsules, 125 mg, 200 mg, 250 mg, and 400 mg - 09/22/2008
Retrovir syrup, capsules and tablets label update for twice daily dosing in children 6 weeks to 18 years of age - 09/14/2008
Tentative approval of abacavir sulfate 60 mg scored tablet for pediatric dosing - 09/03/2008
Tentative approval of abacavir sulfate and lamivudine tablets, 600 mg/300 mg - 09/02/2008
Updated labeling for Norvir (ritonavir) soft capsule and oral solution - 08/21/2008
Important updates to the Reyataz (atazanvir) label - 08/07/2008
Revised Pediatric Treatment Guidelines - 07/23/2008
Important safety-related label update for Ziagen (abacavir sulfate) - 06/27/2008
Zidovudine Oral Solution USP, 50 mg/5 mL generic product approval - 06/27/2008
Important changes to Viramune (nevirapine) oral solution and tablets - 06/23/2008
New pediatric dosing for Aptivus, patients 2-18 years, New Oral Solution and info on coadministration with midazolam - 06/23/2008
New pediatric dosing information for Kaletra, patients 14 days to 6 months and 12-18 years of age and update information on coadministration with midazolam - 06/20/2008
Tentative approval: Fixed dose combination of generic lamivudine/stavudine tablets for pediatric dosing - 06/20/2008
Report of false-positive oral fluid rapid HIV test results - 06/11/2008
Recent updates to Invirase package insert - 05/21/2008
Tentative approval of generic emtricitabine capsules - 05/16/2008
Tentative approval of generic nevirapine tablets - 03/28/2008
Approval of VITROS Anti-HIV 1+2 diagnostic immunoassay - 03/27/2008
Early Communication about an Ongoing Safety Review of Ziagen (Abacavir) and Videx (Didanosine) - 03/26/2008
New pediatric dosing recommendations for Reyataz Capsules, patients ages 6 to 18 years old - 03/24/2008
Tentative approval of two fixed dose combination products for PEPFAR - 03/12/2008
Dear Healthcare Professional letter regarding new prescribing information for Prezista (darunavir) - 03/11/2008
Updates to Prezista (darunavir) tablets labeling - 02/26/2008
New 600 mg tablet strength for Prezista (darunavir) - 02/14/2008
Approval of generic zidovudine tablets, 300 mg - 02/08/2008
Tentative approval of generic atazanavir sulfate capsules - 02/07/2008
New Epivir tablets to facilitate pediatric dosing - 01/29/2008
Tentative approval of generic lamivudine - 01/29/2008
Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents updated - 01/18/2008
Approval of etravirine for treatment-experienced adult patients - 01/16/2008
Reyataz (atazanavir) package insert revisions
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2007
- 12/20/2007
Tentative approval of generic formulation of efavirenz - 12/20/2007
Labeling update for Lexiva ((fosamprenavir) - 12/18/2007
New Warning for Nonoxynol 9 OTC Contraceptive Products re: STDs and HIV/AIDS - 12/17/2007
Updated information regarding antiretroviral agents used as HIV postexposure prophylaxis for occupational HIV exposures - 12/14/2007
FDA proposes requirements for human blood and blood components intended for transfusion or further manufacturing use - 11/30/2007
Tentative approval for a generic version of Tenofovir Disoproxil Fumarate Tablets - 11/30/2007
Tentative approval of generic combination of lamivudine/zidovudine tablets - 11/09/2007
A new half-strength Kaletra formulation approved - 11/05/2007
Final Guidance: The Role of HIV Resistance Testing in Antiretroviral Drug Development - 11/05/2007
Tentative approval of lamivudine/stavudine fixed dose combination - 11/01/2007
Tentative approval of staudine for oral solution - 10/12/2007
New dosing regimen for Lexiva approved - 10/12/2007
FDA approval of Isentress (raltegravir) - 10/11/2007
Traditional approval of Aptivus (tipranavir) - 09/10/2007
Important information about Viracept - 08/14/2007
Tentative approval of new triple fixed dose combination tablet of lamivudine, stavudine and nevirapine - 08/13/2007
Important Dear Healthcare Provider letter about pediatric dosing - 08/13/2007
Tentative approval of generic nevirapine - 08/09/2007
Tentative approval of generic lamuvidine and zidovudine combination tablets - 08/06/2007
Approval of Maraviroc, CCR-5 co-receptor antagonist for treatment of HIV - 07/25/2007
Label changes for BARACLUDE (entecavir) Tablets and Oral Solution - 07/18/2007
Advisory committee meeting scheduled to discuss raltegravir - 07/13/2007
Tentative approval of generic efavirenz - 06/18/2007
FDA approval of Lexiva oral suspension and label changes for pediatric patients and patients with hepatic impairment - 05/25/2007
Three new HIV assays approved - 05/24/2007
Generic zidovudine capsules approved - 04/23/2007
Tentative approval of generic stavudine - 04/23/2007
Updated Kaletra Labeling - 04/18/2007
Change of location notice for April 24, 2007 Antiviral Drugs Advisory Committee meeting - 04/07/2007
Important notice about Combivir and Ziagen - 04/06/2007
Tentative approval of generic abacavir sulfate tablets - 03/27/2007
Tentative approval of efavirenz tablets - 03/19/2007
Tentative approval of lamivudine tablets - 03/16/2007
Two tentative approvals stavudine/lamivudine tablets co-packaged with nevirapine tablets, and stavudine/lamivudine tablets - 03/09/2007
Public Health Advisory: erythropoiesis-stimulating agents (ESAs) - 03/09/2007
Approval of generic didanosine for oral solution - 03/07/2007
Final Guidance: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products - 03/06/2007
Tentative approval lamivudine/zidovudine + nevirapine - 02/26/2007
Baraclude (entecavir) label revisions related to certain HIV-infected patients being treated for chronic hepatitis B - 02/09/2007
Upcoming FDA advisory committee meeting: maraviroc - 01/31/2007
Important changes to Fuzeon product labeling - 01/23/2007
Tentative approval of new fixed dose combination: lamivudine/stavudine
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2006
- 12/29/2006
FDA approves Radiesse for treating facial lipoatrophy - 12/20/2006
Egg Safety during the Holiday Season - 12/12/2006
FDA Proposes Rules to Expand Availability of Investigational Drugs and Clarify Permissible Charges to Patients - 12/01/2006
World AIDS Day - 11/22/2006
Erythropoiesis Stimulating Agents (ESA) Safety Alert - 11/20/2006
Tentative approval of new triple drug Fixed dose combination: stavudine/lamivudine/nevirapine tablets - 11/06/2006
Tentative approval of generic abacavir sulfate - 10/30/2006
Pediatric Guidelines Updated - 10/25/2006
Guidance: Fixed Dose Combinations, Co-Packaged Drug Products, and Previously Approved Antiretrovirals - 10/23/2006
New 300 mg Reyataz capsule approved - 10/11/2006
Revised Adult HIV Treatment Guidelines available - 10/06/2006
Tentative approval of generic didanosine for oral solution - 10/06/2006
Approval of HIV-1 RNA qualitative assay for diagnostic use - 09/14/2006
Tentative approval, fixed dose combination: lamivudine/zidovudine - 09/05/2006
Antiviral Drugs Advisory Committee to discuss design issues in the development of products for treatment of chronic Hepatitis C, including co-infection with HIV - 08/30/2006
Tentative approval of generic stavudine capsules - 08/24/2006
Tentative approval of fixed does lamivudine/zidovudine tablet - 08/14/2006
Tentative approval of generic nevirapine formulation - 08/02/2006
Health warning about raw oysters from Pacific Northwest - 07/26/2006
Tentative approval of lamivudine/zidovudine copackaged with abacavir sulfate - 07/26/2006
Important notification regarding the Vironostika HIV-1 test kit - 07/12/2006
FDA approval of Atripla, 3-drug fixed dose combination antiretroviral - 07/12/2006
Updated Perinatal Guidelines - 07/10/2006
Tentative approval for didanosine chewable tablets - 06/30/2006
Important safety information about Aptivus (tipranavir) - 06/30/2006
Tentative approval for a fixed-dose, three-ingredient tablet to treat HIV/AIDS - 06/28/2006
Tentative approval: generic Abacavir Sulfate Oral Solution - 06/28/2006
Tentative approval: generic stavudine 15 & 20 mg capsules - 06/23/2006
Accelerated approval of Prezista - 06/23/2006
Tentative approval of generic lamivudine oral solution - 06/08/2006
Final Guidance for Industry on Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency - 05/26/2006
Free webcast of CCR5 co-receptor meeting - 05/26/2006
Tentative approval of generic abacavir tablets - 05/05/2006
Development of Preventive HIV Vaccines for Use in Pediatric Populations - 05/04/2006
Updated Adult HIV Treatment Guidelines - 03/31/2006
Generic zidovudine in capsule form - 03/29/2006
Tentative approval of generic zidovudine, 100 mg capsules - 03/10/2006
Traditional approval of Viread and Truvada - 03/08/2006
Tentative approval of copackaged antiviral regimen - lamivudine/zidovudine fixed dose combination tablets and efavirenz tablets - 03/02/2006
OTC HIV Rapid Tests: Issue Summary - 03/01/2006
Notice of upcoming Blood Products Advisory Committee Meeting: Home-use HIV Test - 02/13/2006
Workshop on Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing (NAT) - 02/10/2006
Date set for meeting re: development issues for CCR5 co-receptor antagonists for the treatment of HIV infection - 01/26/2006
Atazanavir labeling changes - 01/18/2006
New Prescription Drug Information Format to Improve Patient Safety
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