News Releases: 2000 - present

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Archive: 1990's | 1980's

 2008

• FDA Approves First Nucelic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue (December 30)
• FDA Approves New HIV Drug After Priority Review (etravirine) (Jan. 18) 

 2007

• FDA Warns Consumers Not to Eat Raw Oysters Harvested from the West Karako Bay Section of Growing Area 3 in Louisiana (Dec. 29)
• FDA Grants Tentative Approval to First Generic for Antiretroviral Viread (Dec. 18)
• FDA Mandates New Warning for Nonoxynol 9 OTC Contraceptive Products: Label must warn consumers products do not protect against STDs and HIV/AIDS (Dec. 18)
• FDA Approves New HIV Drug (raltegravir) (Oct. 16)
• FDA Expands Warning on Eating Raw Oysters from Hood Canal in Washington State (Aug. 24)
• FDA Grants Tentative Approval for 50th and 51st Anti-Retroviral Drugs Under President's AIDS Relief Plan (Aug. 13)
• Consumers Warned to Avoid Eating Raw Oysters from Southern Tip of Hood Canal in Washington State (Aug. 10)
• FDA Approves Novel Antiretroviral Drug (maraviroc) (Aug. 6)
• FDA Warns Consumers Not to Eat Raw Oysters Harvested from the West Karako Bay Section of Growing

 2006

• FDA Proposes Rules Overhaul to Expand Availability of Experimental Drugs (Dec. 11)
• FDA Approves Test to Help Diagnose Main Virus that Causes AIDS (Oct. 5)
• FDA Updates Consumer Advisory to Avoid Certain Raw Shellfish from the Pacific Northwest (Aug. 11)
• Consumers Advised To Avoid Raw Oysters From the Pacific Northwest (July 31)
• FDA Approves the First Once-a-Day Three-Drug Combination Tablet for Treatment of HIV-1 (July 12)
  
• FDA Grants Tentative Approval of a Three-Component AIDS Drug In Association with the President's Emergency Plan for AIDS Relief (June 30)
• FDA Gives Tentative Approval for Another First Time Generic Pediatric AIDS Drug in Association with the President’s Emergency Plan for AIDS Relief (June 27)
• FDA Approves New HIV Treatment for Patients Who Do Not Respond to Existing Drugs (June 23)
• FDA Gives Tentative Approval to New Generic AIDS Drug in Association with the President’s Emergency Plan for AIDS Relief (May 18)
• FDA Tentatively Approves a Co-package of Generic AIDS Drugs in Association with the President’s Emergency Plan for AIDS Relief (March 31)
• FDA Approves First Generic HIV/AIDS Drug in Capsule Form for United States Market (March 31)
• FDA Approves New Treatment for Fungal Infections (Feb. 21)

 2005

• FDA Tentatively Approves a Generic AIDS Drug in Association with the President's Emergency Plan for AIDS Relief (Dec. 21)
• FDA Tentatively Approves a Generic AIDS Drug in Association with the President’s Emergency Plan for AIDS Relief (Nov. 4)
• FDA Approves First Pediatric Generic AIDS Drug for U.S. Marketing (Sept. 19)
• FDA Tentatively Approves Generic Zidovudine Oral Solution, for HIV/AIDS Treatment in Association with the President’s Emergency Plan for AIDS Relief (Sept. 8)
• HHS/FDA Tentatively Approves Another First-Time Generic AIDS Drug Associated with the President's Emergency Plan for AIDS Relief (July 13)
• HHS/FDA Tentatively Approves Another First-Time Generic AIDS Drug (July 8)
• FDA Tentatively Approves Another First Time Generic AIDS Drug Associated with the President’s Emergency Plan for AIDS Relief (July 1)
• FDA Tentatively Approves Generic Efavirenz (June 24)
• FDA Approves BiDil Heart Failure Drug for Black Patients (June 23)
• FDA Approves New Therapy for HIV Patients with Advanced Disease (June 23)
• FDA Tentatively Approves a Generic AIDS Drug under the President's Emergency Plan for AIDS Relief (June 15)
• FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media (February 7)
• FDA Grants Tentative Approval to Generic AIDS Drug Regimen for Potential Purchase Under the President's Emergency Plan for AIDS Relief (January 25)

 2004

• FDA Approves Sculptra for HIV Patients (August 3)
• FDA Approves Two Fixed-Dose Combination Drug Products for the Treatment of HIV-1 Infection (August 2)
• FDA Approves First Oral Fluid Based Rapid HIV Test Kit (March 26)

 2003

• FDA Approves a Once Daily Protease Inhibitor for HIV Infection (June 20)
• FDA Approves First Drug in New Class of HIV Treatments for HIV Infected Adults and Children with Advanced Disease (March 14)
• FDA Issues Guidance for Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Products (January 23)
• FDA Proposes New Warning for Over-the-Counter Contraceptive Drugs Containing Nonoxynol-9 (January 16)
• HHS Extends Use of Rapid HIV Test to New Sites Nationwide (January 31)

 2002

• FDA Approves New Rapid HIV Test Kit (November 7)
• FDA Updates Consumer Advisory about Raw and Lightly Cooked Sprouts (October 2)
• FDA and FSIS Issue Health Advisory About Listeria (September 13
• 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) (February 28)

 2001

• Maryland Businessman Sentenced for Illegally Marketing Aloe Vera Compounds as AIDS and Cancer Treatments (December 5)
• FDA/VA Interagency Agreement, to improve clinical knowledge of adverse effects of drugs used to treat HIV infection (November 20)
• FDA Approves Viread for HIV-1 Infection. FDA approved Viread on October 26, 2001, the first nucleotide analog approved for HIV-1 infection treatment in combination with other antiretroviral medicines. (October 29)
• FDA Approves First Nucleic Acid Test (NAT) systems to Screen Plasma for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). The FDA has licensed the first nucleic acid test (NAT) systems intended for screening of plasma donors. These test systems are expected to further ensure the safety of plasma-derived products by permitting earlier detection of HIV and HCV infections in donors. (September 21)
• FDA approved a supplemental biologics application for PEG-Intron (peginterferon alfa-2b), an injectable product approved to treat patients with chronic hepatitis C infections, to be used in combination with REBETOL capsules (ribavirin) (August 8)
• FDA Approves Stand-Alone Package (Unbundled) Package for Rebetol Capsules for use with Intron A for the treatment of chronic hepatitis C infection (July 26)
• Scientific Review Panel Confirms Condoms Are Effective Against HIV/AIDS, But Epidemiological Studies Are Insufficient for Other STDs (HHS, July 20)
• Operation Cure All Battle Internet Health Fraud, FDA joined with the Federal Trade Commission (FTC) and others in a program aimed at stopping Internet scams that promote dietary supplements, devices, and other products as cures or treatments for HIV/AIDS and other life-threatening diseases. (FTC, June 14)
• FDA/Bristol Myers Squibb Issues Caution for HIV Combination Therapy with Zerit and Videx in Pregnant Women (January 5)

 2000

• Safety Alert on Unapproved Goat Serum Treatment for HIV/AIDS,  Potential Safety Concern involving Unapproved Experimental Product for HIV/AIDS (December 22)
• FDA Approves Trizivir for HIV (November 15)
• FDA Approves Kaletra for HIV Infection (September 15)
• California IVD Firm Signs Consent Decree with FDA; Agrees to Stop Manufacturing, Correct Violations (June 19)