For Consumers
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HIV/AIDS What's New Archive
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2005
- 12/27/2005
Tentative approval of nevirapine oral suspension - 12/22/2005
Tentative approval for pediatric formulation of stavudine - 12/21/2005
Reports of false positive oral rapid test results - 12/07/2005
Tenth anniversary of the first protease inhibitor approval - 12/01/2005
CCR5 antagonist meeting postponed - 11/21/2005
CCR5 co-receptor antagonists meeting announcement - 11/17/2005
Proposed Guidance for Condom Labeling - 11/17/2005
Perinatal Guidelines Update - 11/04/2005
Pediatric Treatment Guidelines Updated - 10/28/2005
FDA approval of new formulation of Kaletra - 10/13/2005
Notice of upcoming Blood Products Safety Advisory Committee meeting - 10/06/2005
Dosing recommendations for NORVIR (ritonavir) in pediatric patients one month to two years of age - 09/28/2005
Emtriva: New formulation and labeling changes - 09/23/2005
Important Recommendations for Non-HIV-Specialize d Providers Caring for Displaced HIV-Infected Residents from the Hurricane Disasters - 09/20/2005
Approval of generic zidovudine formulations for US market - 09/07/2005
Tentative approval of generic zidovudine - 08/16/2005
PDE-5 Inhibitors and HIV Risk: Conference Notice - 07/07/2005
Tentative approval of generic lamivudine/zidovudine combination - 07/01/2005
Tentative approval or generic stavudine - 06/23/2005
FDA approval of Aptivus (tipranavir) - 05/31/2005
Approval of generic foscarnet sodium for treatment of CMV retinitis - 05/26/2005
Fortovase distribution to be discontinued - 05/25/2005
FDA Issues Draft Guidance for the Development of Antiviral Drug Products - 05/13/2005
New 30-count Size Bottle Approved for Norvir (ritonavir) 100 mg Soft Gelatin Capsules - 05/13/2005
New Labeling for Viread (tenofovir disoproxil fumarate) - 04/29/2005
Approval of KALETRA 800/200mg Once-daily Administration for the Treatment of HIV-infection in Therapy-naïve Adult Patients - 04/08/2005
Adult Treatment Guidelines Updated - 04/04/2005
Notice of Upcoming Advisory Committee Meeting - Tipranavir - 03/31/2005
Important Information About Sustiva (efavirenz) and Pregnancy - 03/30/2005
Approval of Baraclude (entecavir) for Treatment of Chronic Hepatitis B Virus Infection - 03/24/2005
Updated Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection - 03/02/2005
Pegasys and Copegus Indications Expanded to Include Treatment of Hepatitis C and HIV Coinfection - 02/08/2005
Drug Interaction Warning: Saquinavir/ritonavir and Rifampin - 02/07/2005
FDA Warning - Unapproved Home-use Diagnostic Test Kits - 01/26/2005
Tentative Approval of Copackaged Antiretroviral for PEPFAR Availability
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2004
- 12/30/2004
Approval of Multispot HIV-1 / HIV-2 Rapid Test - 12/27/2004
Crixivan (indinavir) label revised ~ Not recommended for HIV-infected pregnant patients - 12/20/2004
Atazanavir, with or without ritonavir should not be coadministered with proton pump inhibitors - 12/17/2004
New 500 mg Tablet Formulation of Invirase (saquinavir) Approved - 12/03/2004
Approval of Generic ddI - 12/01/2004
Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection Update - 11/26/2004
Draft Guidance: Role of HIV Drug Resistance Testing in Antiretroviral Drug Development - 11/17/2004
Final Guidance: Use of Nucleic Acid Tests for Blood Screening for HIV-1 and HCV - 11/12/2004
Dear Healthcare Provider letter regarding early virologic failures on Videx/Viread - 10/29/2004
Availability of Revised HIV Treatment Guidelines - 10/22/2004
Fuzeon (enfuvirtide, T-20) Accelerated to Traditional Approval / Label Revisions - 10/22/2004
Kaletra (lopinavir and ritonavir) Labeling Revisions - 09/14/2004
Exploring Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies - 09/08/2004
Meeting of FDA's Vaccines and Related Biological Products Advisory Committee - 08/17/2004
Sustiva labeling revisions - 08/03/2004
FDA approval of Sculptra for treating facial lipoatrophy - 08/02/2004
Two new Fixed Dose Combinations Approved - 07/27/2004
New HIV/AIDS Advisory Committee Records Web Page - 07/07/2004
New Dosing Regimen for REYATAZ/ritonavir in Treatment-Experienced Patients - 07/06/2004
VIREAD (tenofovir disoproxil fumerate) Label Update - 05/21/2004
CLIA Waiver granted to OraQuick ADVANCE Rapid HIV-1/2 Antibody Test - 05/20/2004
New Rule and Draft Guidance Issued for Human Cell and Tissue Donor Screening - 05/12/2004
Changes to Crixivan (indinavir sulfate) capsules product label and patient package insert - 05/04/2004
Labeling changes for Voriconazole (VFEND) antifungal, when coadministered with efavirenz or ritonavir - 04/07/2004
FDA Approval of Generic Ribavirin for Treatment of Chronic Hepatitis C - 03/26/2004
3 issues related to Rapid Testing for HIV - 03/22/2004
Revised Pediatric Dosing Recommendations for Viracept (nelfinavir) - 03/19/2004
Important new information about atazanavir drug interaction - 01/13/2004
Changes to Crixivan Labeling - 01/02/2004
FDA Approval of New, 10 Minute Rapid HIV Test
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2003
HIV list serve archive, 2003
- 12/29/2003
New Dosing Regimens for INVIRASE and FORTOVASE (saquinavir) - 11/14/2003
Revised Adult HIV Treatment Guidelines - 11/04/2003
Revised labeling for VIREAD (tenofovir disoproxi l fumarate) 300mg Tablets - 10/21/2003
FDA approves LEXIVA (Fosamprenavir calcium) - 10/16/2003
Medication Dispensing Errors ~ Kaletra (lopinavir/ritonavir) and Keppra (levetiracetam) - 10/14/2003
Important Drug Warning: Once-Daily Triple NRTI Regimen containing Didanosine, Lamivudine, and Tenofovir - 10/10/2003
Live Help is now available on AIDSinfo.nih.gov - 10/09/2003
Recent Changes to Norvir (ritonavir) Product Labeling - 08/15/2003
New Information in Viread Label - 08/08/2003 Information posted for Advisory Committee Meeting - development of topical microbicides to reduce HIV transmission
- 08/08/2003
New information about treatment of Latent Tuberculosis Infection in HIV infected and Uninfected Individuals - 07/25/2003
Dear Health Care Provider Letter from GlaxoSmithKline (re: Lamivudine, Abacavir and Tenofovir) - 07/02/2003
FDA Approval of Emtriva for treating HIV - 06/23/2003
FDA Approves Atazanavir, a Once Daily Protease Inhibitor for HIV Infection - 06/12/2003
Advisory Committee Meeting Notice - development of topical microbicides to reduce HIV transmission - 04/30/2003
FDA approves new, alternate dosing formulation of Viracept - 04/28/2003
A Catalog of FDA Approved Drug Products - 04/04/2003
Antiviral Drugs Advisory Committee Meeting - Atazanavir / valacyclovir - 04/01/2003
Integrating Nutrition Therapy into Medical Management of HIV - 03/13/2003
FDA approves Fuzeon - 03/12/2003
Counterfeit Procrit - 03/11/2003
FDA Proposes Labeling and Manufacturing Standards For All Dietary Supplements - 02/24/2003
Pediatric Advisory Committee Meeting: HIV drug development in neonates - 01/16/2003
FDA proposes warning labeling for OTC vaginal contraceptives containing nonoxynol 9
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2002
HIV list serve archive, 2002
- 12/31/2003
Approval of ZERIT® XR, a new formulation that allows once-a-day dosing - 12/02/2002
Launch of new AIDSInfo Website - 11/07/2002
FDA approves new rapid HIV test kit - 11/01/2002
New guidance on clinical trial design in developing treatment for HIV infection - 10/11/2002
Anitviral Advisory Committee to consider application for peginterferon alfa-2a + ribavirin for treatment of Hepatitis C - 09/25/2002
New Safety Information -Viread co-administration with Videx - 09/25/2002
New Safety Information for Videx (Didanosine, ddI) used with Ribavirin - 09/23/2002
FDA Approves Viral Load Test ~ VERSANT® HIV-1 RNA 3.0 Assay (bDNA) - 09/23/2002
FDA Approves new treatment for chronic Hepatitis B - see note on HIV resistance - 09/06/2002
Availability of nandrolone decanoate - 08/12/2002
Important Changes in Agenerase Product Labeling - 07/03/2002
Prescription drug information for patients - 07/02/2002
New Dosing approved for Epivir (lamivudine) - 06/12/2002
Important information about counterfeit PROCRIT (epoetin alfa) - Two lot numbers - 05/12/2002
Important information about counterfeit EPOGEN - 05/20/2002
Notification of Counterfeit Serostim - 05/15/2002
Product Tampering that Incorrectly Labels Ziagen as Combivir - 03/01/2002
Changes in ZERIT product labeling reflect potential safety concerns - 02/15/2002
Cytovene-IV Shortage - additional information
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Contact FDA
301-796-8460
Office of Special Health Issues
10903 New Hampshire Avenue
Bldg. 32, Room 5367
Silver Spring, MD 20993
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