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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

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2011

2011

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2010

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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

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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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