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Agency: Food and Drug Administration (FDA)
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- FDA Approves New HIV Drug After Priority Review (Release Date: 01/18/2008)
- FDA Approves the First Integrase Inhibitor, Raltegravir - October 12, 2007 (Release Date: 10/12/2007)
- Approval of maraviroc (Release Date: 08/06/2007)
- FDA approval of Lexiva oral suspension and label changes for pediatric patients and patients with hepatic impairment (Release Date: 06/18/2007)
- Important Notice about Combivir and Ziagen (Release Date: 04/10/2007)
- Atazanavir Labeling Changes (Release Date: 11/27/2006)
- HIV-1 RNA Qualitative Assay Approval (Release Date: 10/05/2006)
- FDA Statement on Foodborne E. coli O157:H7 Outbreak in Spinach (Release Date: 09/24/2006)
- Upcoming Advisory Committee Meeting (Release Date: 09/22/2006)
- Health Warning About Raw Oysters from Pacific Northwest (Release Date: 08/02/2006)
- Important Notification Regarding the Vironostika HIV-1 test kit. (Release Date: 07/26/2006)
- Tentative approval of lamivudine/zidovudine copackaged with abacavir sulfate (Release Date: 07/26/2006)
- FDA Approves the First Once-a-Day Three-Drug Combination Tablet for Treatment of HIV-1 (Release Date: 07/12/2006)
- FDA Grants Tentative Approval of a Three-Component AIDS Drug (Release Date: 06/30/2006)
- Important safety information about Aptivus ( tipranavir) (Release Date: 06/30/2006)
- FDA Gives Tentative Approval for Another First Time Generic Pediatric AIDS Drug in Association with the President¿s Emergency Plan for AIDS Relief (Release Date: 06/27/2006)
- FDA Approves New HIV Treatment for Patients Who Do Not Respond to Existing Drugs (Release Date: 06/27/2006)
- FDA Approval of Prezista (Release Date: 06/26/2006)
- New Guidance on Antiviral Product Development (Release Date: 06/09/2006)
- Product Approval Information - Licensing Action: GARDASIL® Questions and Answers (Release Date: 06/08/2006)
- FDA/Forum for Collaborative HIV Research Collaborative Meeting on Long-Term Safety Concerns Associated with CCR5 Antagonist Development (Release Date: 05/31/2006)
- Generic zidovudine in Capsule Form (Release Date: 03/31/2006)
- Traditional Approval of Viread and Truvada (Release Date: 03/08/2006)
- OTC HIV Rapid Tests: Issue Summary (Release Date: 03/03/2006)
- FDA Notice of Upcoming Blood Products Advisory Committee Meeting: Home-Use HIV Test (Release Date: 03/01/2006)
- FDA approval of new formulation of Kaletra (Release Date: 10/28/2005)
- Emtriva: New Formulation and Labeling Changes (Release Date: 09/29/2005)
- FDA Approves First Pediatric Generic AIDS Drug for U.S. Marketing (Release Date: 09/19/2005)
- Tentative Approval Generic Zidovudine Oral Solution (Release Date: 09/07/2005)
- PDE-5 Inhibition and HIV Risk: Current Concepts and Controversies (Release Date: 08/17/2005)
- FDA Approval of Aptivus (tipranavir) (Release Date: 06/21/2005)
- FDA Tentatively Approves First Generic Nevirapine under the President's Emergency Plan for AIDS Relief (Release Date: 06/20/2005)
- FDA Tentatively Approves a Generic AIDS Drug under the President's Emergency Plan for AIDS Relief (Release Date: 06/15/2005)
- FDA Approves Generic Version of Foscavir (Release Date: 05/31/2005)
- Dear Health Care Provider Letter Regarding the Discontinuation of Fortovase (Release Date: 05/26/2005)
- FDA Approves Once-Daily Dosage of Kaletra for Therapy-Naïve Adult Patients (Release Date: 04/29/2005)
- The Food and Drug Administration (FDA) is announcing a meeting of its Antiviral Drugs Advisory Committee May 19, 2005. (Release Date: 04/04/2005)
- FDA Public Health Advisory for Nevirapine (Viramune)-January 19, 2005 (Release Date: 01/19/2005)
- New information about coadministration of REYATAZ (atazanavir) and Norvir (ritonavir) with Prilosec (omeprazole) - December 20, 2004 (Release Date: 12/20/2004)
- FDA approves generic formulation of didanosine (ddI) delayed release capsules (Release Date: 12/03/2004)
- FDA Approves Sculptra for HIV Patients (Release Date: 08/03/2004)
- FDA Approves Two Fixed-Dose Combination Drug Products For the Treatment of HIV-1 Infection (Release Date: 08/02/2004)
- Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV (Release Date: 05/01/2004)
- FDA Approves First Oral Fluid Based Rapid HIV Test Kit (Release Date: 03/26/2004)
- FDA Issues Draft Guidance on Providing More Information on Investigational Treatment (Release Date: 01/27/2004)
- Drug errors involving Keppra and Kaletra (Release Date: 01/12/2004)
- Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Revision 1) (Release Date: 01/01/2004)
- FDA Approves LEXIVA (Fosamprenavir calcium) to Treat HIV Infection (Release Date: 10/21/2003)
- Drug Warning: Once-daily Triple NRTI Regimen containing Didanosine, Lamivudine, and Tenofovir (Release Date: 10/14/2003)
- Questions and Answers on FluMist (Influenza Virus Vaccine Live, Intranasal) (Release Date: 10/14/2003)
- Inside Clinical Trials: Testing Medical Products in People (Release Date: 09/01/2003)
- Important New Pharmacokinetic Data for REYATAZ(tm) (atazanavir sulfate) in combination with Viread® (tenofovir disoproxil fumarate) (Release Date: 08/08/2003)
- FDA Approves a Once Daily Protease Inhibitor for HIV Infection (Release Date: 06/20/2003)
- Frequently Asked Questions About the OraQuick Rapid HIV-1 Antibody Test (Release Date: 04/04/2003)
- FDA Approves First Drug in New Class of HIV Treatments (Release Date: 03/13/2003)
- FDA Issues Guidance for Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Products (Release Date: 01/23/2003)
- FDA Proposes New Warning for Over-The-Counter Contraceptive Drugs Containing Nonoxynol-9 (Release Date: 01/16/2003)
- Draft Guidance for Industry and Reviewers on Estimating the Safe Starting Dose in Clinical Trails for Therapeutics in Adult Healthy Volunteers (Release Date: 01/01/2003)
- Food and Drug Administration approved a new, extended release formulation of ZERIT (Release Date: 12/31/2002)
- FDA Approves New Rapid HIV Test Kit (Release Date: 11/07/2002)
- Majority of HIV-Infected Mothers and At-Risk Newborns Receive ZDV Treatment in Groundbreaking Thailand Prevention Program (Release Date: 07/06/2002)
- FDA Approves First Nucleic Acid Test (NAT) System To Screen Whole Blood Donors For Infections With Human Immunodeficiency Virus (HIV) And Hepatitis C Virus (HCV) (Release Date: 02/28/2002)
- FDA Approves Viread for HIV-1 Infection (Release Date: 10/29/2001)
- FDA Approves First Nucleic Acid Test (NAT) Systems To Screen Plasma For Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) (Release Date: 09/21/2001)
- FDA/Bristol Myers Squibb Issues Caution for HIV Combination Therapy with Zerit and Videx in Pregnant Women (Release Date: 01/05/2001)
- FDA Issues Safety Alert on Unapproved Goat Serum Treatment for HIV/AIDS (Release Date: 12/22/2000)
- FDA Approves Trizivir for HIV (Release Date: 11/15/2000)
- FDA Approves Kaletra for HIV Infection (Release Date: 09/15/2000)
- Approval of Synercid for Certain Vancomycin Resistant Infections (Release Date: 09/21/1999)
- Attacking AIDS with a 'Cocktail' Therapy: Drug Combo Sends Deaths Plummeting (Release Date: 07/01/1999)
- FDA Approves First Home Test for Hepatitis C Virus (Release Date: 04/29/1999)
- FDA Approves Amprenavir for HIV Infection (Release Date: 04/16/1999)
- The Five Faces of Hepatitis (Release Date: 03/01/1999)
- Hepatitis C: New Treatment Helps Some, but Cure Remains Elusive (Release Date: 03/01/1999)
- FDA Licenses Improved Supplemental Test for Hepatitis C (Release Date: 02/12/1999)
- HIV AIDS History Milestones 1995 - 1998 OSHI (Release Date: 01/19/1999)
- FDA Approves Abacavir for HIV-1 Infection (Release Date: 12/18/1998)
- FDA Approves Hepatitis C Combination Product for Use in Previously Untreated Patients (Release Date: 12/09/1998)
- Protease Inhibitors May Increase Blood Glucose in HIV Patients (Release Date: 12/01/1998)
- Fresh Citrus Juice Manufacturers Can Ask for Extra Time Before Warning Labels Are Required (Release Date: 10/23/1998)
- FDA Approves New Drug to Treat HIV, AIDS (Release Date: 09/18/1998)
- FDA Clears Tuberculosis Drug for Marketing (Release Date: 06/23/1998)
- FDA Approves New Formulation of First Protease Inhibitor Saquinavir (Release Date: 11/07/1997)
- FDA Approves First Combination Drug for AIDS (Release Date: 09/29/1997)
- FDA Proposes Rule on Women in Clinical Trials (Release Date: 09/23/1997)
- FDA Announces a Strategy to Increase Safety of Fresh Juices (Release Date: 08/26/1997)
- Approved Therapies for HIV/AIDS or AIDS-related Conditions (Release Date: 06/17/1997)
- Diabetes and Hyperglycemia in Patients Receiving Protease Inhibitors (Release Date: 06/11/1997)
- Health Advisory For Newest Class Of Aids Drugs (Release Date: 06/11/1997)
- FDA Approves First Protease Inhibitors With Labeling for Use in Children (Release Date: 03/14/1997)
- FDA Proposes New Use Initiative (Release Date: 03/13/1997)
- New Xenotransplantation Guideline Available (Release Date: 09/20/1996)
- FDA Approves Drug for AIDS Wasting (Release Date: 08/23/1996)
- The Protease Inhibitors (Release Date: 07/01/1996)
- FDA Approves Cidofovir for AIDS-Related Retinitis (Release Date: 06/27/1996)
- FDA Approves Nevirapine to Treat HIV (Release Date: 06/24/1996)
- FDA aprueba Nevirapina para tratar el VIH (Release Date: 06/24/1996)
- FDA Approves New Test to Measure HIV Levels in Blood (Release Date: 06/03/1996)
- Milestones 1981-1997 (Release Date: 06/01/1996)
- Expanded Access and Expedited Approval of New Therapies Related to HIV/AIDS (Release Date: 06/01/1996)
- FDA Approves First HIV Home Test System (Release Date: 05/14/1996)
- Home-Use HIV Test Kits (Release Date: 05/14/1996)
- An FDA Guide to Choosing Medical Treatments (Release Date: 05/01/1996)
- FDA Grants Accelerated Approval To Third Protease Inhibitor To Treat HIV (Release Date: 03/14/1996)
- FDA Approves First Test for HIV Antigen Screening of Blood Donors (Release Date: 03/14/1996)
- FDA Panel Recommends Approval of Third Protease Inhibitor (Release Date: 03/08/1996)
- FDA Approves Second Protease Inhibitor to Treat HIV (Release Date: 03/01/1996)
- Thalidomide Update (Release Date: 02/26/1996)
- FDA aprueba el primer medicamento inhibidor de proteasa para el tratamiento del VIH (Release Date: 12/07/1995)
- FDA Approves First Protease Inhibitor Drug for Treatment of HIV (Release Date: 12/07/1995)
- FDA Grants Accelerated Approval for 3TC with AZT to Treat AIDS (Release Date: 11/20/1995)
- Las subvenciones de la FDA aceleraron la aprobación de 3TC con AZT para tratar el SIDA (Release Date: 11/20/1995)
- FDA Panel Recommends Approval of New AIDS Drug (Release Date: 11/15/1995)
- FDA Panel Recommends Approval of 3TC with AZT to Treat AIDS (Release Date: 11/07/1995)
- Approval of The First U.S. HIV Test System Using Oral Fluid Samples (Release Date: 12/23/1994)
- Oral Ganciclovir Approved (Release Date: 12/22/1994)
- Treatment IND for AIDS-related Wasting Authorized (Release Date: 12/21/1994)
- AZT Approved for Preventing Maternal-Fetal HIV Transmission (Release Date: 08/08/1994)
- Aprobación de la Stavudina (d4T) por el FDA (Release Date: 06/27/1994)
- FDA Approval of Stavudine (d4T) (Release Date: 06/27/1994)
- FDA Licenses IGIV For Two New Indications (Release Date: 01/03/1994)
- Trimetrexate Approved For Treatment of PCP (Release Date: 12/20/1993)
- Women in Clinical Trials (Release Date: 12/01/1993)
- Approval of supplemental application for streptomycin sulfate. (Release Date: 05/17/1993)
- FDA Plans Policy Change on Women in Clinical Trials (Release Date: 04/05/1993)
- Partial Results of AZT Study Reported in Lancet (Release Date: 04/02/1993)
- Second Recombinant Antihemophilic Factor Licensed (Release Date: 03/01/1993)
- Rifabutin Approval (Release Date: 12/23/1992)
- FDA Approves New Indication For Dronabinol (Release Date: 12/23/1992)
- Atovaquone Receives Approval for Treatment of PCP (Release Date: 11/27/1992)
- Vaginal Candidiasis May Sometimes Be An Early Warning of HIV Infection (Release Date: 11/16/1992)
- First AIDS Drug Tested Under Parallel Track Policy; other d4T related press releases (Release Date: 10/05/1992)
- ddI Receives Additional Approval (Release Date: 10/01/1992)
- Approval of Zalcitabine (Release Date: 06/22/1992)
- Advisory Committee Recommends Approval of ddC as Combination AIDS Therapy (Release Date: 04/21/1992)
- New initiatives to Speed Access to New Drugs (Release Date: 04/09/1992)
- Atovaquone (566C80) Receives Treatment IND Status for AIDS Related Use (Release Date: 11/12/1991)
- HHS Secretary Louis W. Sullivan announces FDA's approval of ddI. (Release Date: 10/09/1991)
- Foscarnet Approved (Release Date: 09/27/1991)
- First Combination Test Kit Licensed for Detecting HIV-I and HIV-2 (Release Date: 09/26/1991)
- Granulocyte Colony-Stimulating Factor Approved to Protect Cancer Chemotherapy Patients (Release Date: 02/21/1991)
- Epoetin Alfa For AIDS Related Condition (Release Date: 01/02/1991)
- Granulocyte Macrophage Colony-Stimulating Factor (Release Date: 09/24/1990)
- AZT for Children (Release Date: 05/03/1990)
- HIV 2 Test Kit Approved (Release Date: 04/25/1990)
- Expanded Labeling for AZT (Release Date: 03/02/1990)
- Second Aerosolized Pentamidine Approval (Release Date: 06/15/1989)
- Alpha Interferon Approval for Kaposi's Sarcoma (Release Date: 11/21/1988)