Index of Articles From Food and Drug Administration
Videx EC Labeling Changes With Pediatric Dosing Information Added Updated Labeling for Norvir (Ritonavir) Soft Capsule and Oral Solution Important Updates to the Reyataz (Atazanvir) Label Revised Pediatric Treatment Guidelines Important Safety-Related Label Update for Ziagen (Abacavir Sulfate) New Pediatric Dosing for Aptivus, Patients 2-18 Years, New Oral Solution and Info on Coadministration With Midazolam 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 Recent Updates to Invirase Package Insert Early Communication About an Ongoing Safety Review of Ziagen (Abacavir) and Videx (Didanosine) New Pediatric Dosing Recommendations for Reyataz Capsules, Patients Ages 6 to 18 Years Old here
Updates to Prezista (Darunavir) Tablets Labeling FDA Warns Companies Importing and Marketing Drugs Over the Internet that Fraudulently Claim to Prevent and Treat STDs New 600-mg Tablet Strength for Prezista (Darunavir) Epivir Tablets for Pediatric Dosing Vital Facts About HIV Home Test Kits click here
Intelence (TMC125, Etravirine) Approved by U.S. FDA Reyataz (Atazanavir) Package Insert Revisions Drugs Used in the Treatment of HIV Infection
Labeling Update for Lexiva (Fosamprenavir) FDA Mandates New Warning for Nonoxynol 9 OTC Contraceptive Products New Dosing Regimen for Lexiva Approved FDA Approval of Isentress (Raltegravir) Important Information About Viracept Approval of Maraviroc Label Changes for Baraclude (Entecavir) Tablets and Oral Solution FDA Approval of Lexiva Oral Suspension and Label Changes for Pediatric Patients and Patients With Hepatic Impairment Three New Assays Approved Generic Drugs Used in the Treatment
of HIV Infection Drugs Used to Treat Complications of HIV/AIDS Drugs Used in the Treatment of Pediatric HIV Infection Important Information Regarding Baraclude (Entecavir) in Patients Co-Infected With HIV and HBV Important Update to Sustiva Package Insert Important Changes to Fuzeon Product Labeling
FDA Approves Radiesse for Treating Facial Lipoatrophy Egg Safety During the Holiday Season FDA Proposes Rules to Expand Availability of Investigational Drugs and Clarify Permissible Charges to Patients New 300 mg Reyataz Capsule Approved FDA Approves Test to Help Diagnose Main Virus That Causes AIDS Health Warning About Raw Oysters From Pacific Northwest Approval of Atripla Important Safety Information About Aptivus (Tipranavir) Prezista Approval FDA Approves First Generic HIV/AIDS Drug in Capsule Form for United States Market Over-the-Counter HIV Rapid Tests: Issue Summary Labeling Changes for Atazanavir (Reyataz) here
New Prescription Drug Information Format to Improve Patient Safety Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
December 1 Is World AIDS Day Perinatal Guidelines Update FDA Approval of New Formulation of Kaletra Dosing Recommendations for Norvir (Ritonavir) in Pediatric Patients One Month to Two Years of Age Labeling Changes for Emtriva Emtriva: New Formulation and Labeling Changes Approval of Generic Zidovudine FDA Approval of Aptivus (Tipranavir) Eating Defensively: Food Safety Advice for Persons With AIDS Viread (Tenofovir Disoproxil Fumarate) Labeling Revision Norvir (Ritonavir) Available in New Package Size Kaletra Once-Daily Dosage for Therapy-Naive Adult Patients Important Information About Sustiva (Efavirenz) and Pregnancy FDA Approves Baraclude (Generic Name: Entecavir) for Treatment of Hepatitis B Notice of Important New Drug Interactions Drug Interaction Warning: Saquinavir/Ritonavir and Rifampin here FDA Public Health Advisory for Nevirapine (Viramune)
Crixivan (Indinavir) Label Revised -- Not Recommended for HIV-Infected Pregnant Patients Atazanavir, With or Without Ritonavir, Should Not Be Coadministered With Proton Pump Inhibitors New 500-mg Tablet Formulation of Invirase (Saquinavir) Approved Important New Clinical Data Potential Early Virologic Failure Associated With the Combination Antiretroviral Regimen of Tenofovir Disoproxil Fumarate, Didanosine, and Either Efavirenz or Nevirapine in HIV Treatment-Naive Patients with High Baseline Viral Loads here
Fuzeon (Enfuvirtide, T-20) Accelerated to Traditional Approval/Label Revisions Kaletra (Lopinavir and Ritonavir) Labeling Revisions Approval of Sculptra for Treating Facial Lipoatrophy Two New Fixed-Dose Combinations Approved New Dosing Regimen for Ritonavir-Boosted Atazanavir in Treatment-Experienced Patients; Revisions Made to Packaging Insert Food and Drug Administration (FDA) Warning Letter to Abbott Laboratories FDA Approves First Oral Fluid Based Rapid HIV Test Kit
Questions and Answers on Hepatitis A Outbreaks Associated With Eating Raw or Undercooked Green Onions (Scallions) Consumers Advised That Recent Hepatitis A Outbreaks Have Been Associated With Green Onions Revised Labeling for Viread (Tenofovir Disoproxil Fumarate) 300 mg Tablets FDA Approves Lexiva (Fosamprenavir Calcium) Important Drug Warning: High Rate of Virologic Failure in Patients With HIV Infection Treated With a Once-Daily Triple NRTI Regimen Containing Didanosine, Lamivudine, and Tenofovir here
Important New Pharmacokinetic Data for Reyataz (Atazanavir Sulfate) in Combination With Viread (Tenofovir Disoproxil Fumarate) Early Virologic Non-Response in Patients With HIV Infection Treated With Lamivudine, Abacavir and Tenofovir Approval of Emtriva for Treating HIV Approved Drugs for HIV/AIDS and AIDS-Related Conditions FDA Grants Approval of BMS' Reyataz for Combination Therapy in HIV Treatment Fuzeon (T-20) Approved in the U.S. Counterfeit Procrit Alert FDA Proposes Labeling and Manufacturing Standards Dietary Supplements -- Factsheet FDA Proposes Labeling and Manufacturing Standards for all Dietary Supplements FDA Proposes Manufacturing and Labeling Standards for all Dietary Supplements -- Backgrounder HHS Extends Use of Rapid HIV Test to New Sites Nationwide How to Take Charge of Food Safety at Home FDA Consumer magazine
2002
Approval of Zerit XR, a New Formulation That Allows Once-a-Day Dosing FDA Approves New Rapid HIV Test Kit New Guidance on Clinical Trial Design in Developing Treatment for HIV Infection Consumers Advised of Risks Associated With Raw Sprouts New Safety Information -- Viread Co-Administration With Videx New Safety Information for Videx (Didanosine, ddI) Used With Ribavirin FDA Approves New Treatment for Chronic Hepatitis B FDA and FSIS Issue Health Advisory About Listeria Important Drug Warning: Counterfeiting of Epogen here
GlaxoSmithKline Alerts Patients, Pharmacists and Physicians to Watch for Third-Party Tampering That Incorrectly Labels Ziagen as Combivir Important Drug Warning: Counterfeiting of Epogen Kava-Containing Dietary Supplements May Be Associated With Severe Liver Injury FDA Issues Consumer Advisory That Kava Products May Be Associated With Severe Liver Injury 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) 2002 Safety Alert: Cytovene IV (Ganciclovir Sodium for Injection) Changes in Zerit Product Labeling Reflect Potential Safety Concerns
2001
Important Drug Warning: Intron A Living with AIDS -- 20 Years Later The Last Word: Living with the Enemy -- Never Letting Our Guard Down Home Diagnostic Tests: The Ultimate House Call? FDA Approves Viread for HIV-1 Infection Viread Product Information (August 2003) (PDF)
Important Drug Warning: Roferon-A Foodborne Illness: What Consumers Need To Know FDA Approves Stand-Alone Package of Rebetol (Ribavirin) for Combination Therapy with Intron A for the Treatment of Chronic Hepatitis C Infection Rebetol (Ribavirin) Product Information (2001) (PDF)
FDA Sponsored AIDS Health Fraud Task Forces FDA Issues Health Advisory Regarding the Safety of Sporanox® Products and Lamisil® Tablets to Treat Fungal Nail Infections Revised Package Insert: Roferon-A (Interferon Alfa-2a, Recombinant) Frequently Asked Questions Concerning Thalidomide Notice of FDA Advisory Committee Meeting on February 27, 2001 Revised Package Insert: Intron A (Interferon Alfa-2b, Recombinant for Injection) FDA Issues Urgent Notice of Recalled Injectable Drugs Testing Yourself for HIV-1, the Virus that Causes AIDS FDA/Bristol Myers Squibb Issues Caution for HIV Combination Therapy with Zerit and Videx in Pregnant Women Important Drug Warning
2000
1999
FDA Takes Action Against Firm Marketing Unapproved Drugs HIV/AIDS Milestones 1995-1999 Internet Sales of Bogus HIV Test Kits Result in First-of-Kind Wire Fraud Conviction FDA Consumer magazine
Attacking AIDS with a 'Cocktail' Therapy: Drug Combo Sends Deaths Plummeting FDA Consumer magazine
Chlamydia's Quick Cure FDA Approves First Home Test for Hepatitis C Virus FDA Approves Amprenavir For HIV Infection Hepatitis C: New Treatment Helps Some, but Cure Remains Elusive FDA Consumer magazine
Critical Steps Toward Safer Seafood FDA Consumer magazine
1998
FDA Approves Abacavir for HIV-1 Infection Sustiva Consumer Information Antiretroviral Drugs Approved By FDA for HIV FDA Approves New Drug to Treat HIV, AIDS Fight BAC! Four Simple Steps to Food Safety (Food-Borne Illness) True/False Test Approval Letter for the Use of Vitravene Injection for the Local Treatment of Cytomegalovirus (CMV) Retinitis FDA Strengthens Warning Label for Propulsid Discussion of the Guidelines for the Use of Antiretroviral Agents In Pediatric HIV Infection, July 22, 1998 On the Teen Scene: Preventing STDs FDA Consumer magazine
Condoms: Barriers to Bad News FDA Consumer magazine
Satellite Broadcast Downlink Program to Discuss the Guidelines for the Use of Antiretroviral Agents In HIV-Infected Adults and Adolescents, February 27, 1998 A Response to the Current Difficulty in Obtaining Immune Globulin Intravenous (Human) (IGIV) Protease Inhibitors Backgrounder
1987 - 1997
FDA Scientists Uncover Factors in the Selective Nature of Sexually-Transmitted HIV Rallying the Troops to Fight Food-Borne Illness FDA Consumer magazine
FDA Approves New Formulation of First Protease Inhibitor Saquinavir FDA, States Collaborate for Safety's Sake Focus on Food Safety -- Initiative Calls on Government, Industry, Consumers to Stop Food-Related Illness FDA Consumer magazine
FDA Approves First Combination Drug for AIDS Thalidomide: Important Patient Information Equality in Clinical Trials: Drugs and Gender Giving Thalidomide a Second Chance New Ways to Prevent and Treat AIDS Homeopathy: Real Medicine or Empty Promises? FDA Consumer magazine: Making It Easier to Read PrescriptionsAn FDA Guide to Choosing Medical Treatments Protecting Patients and Professionals from Blood-Borne Diseases Important Health Information for People With Immune Disorders Handling Eggs Safely at Home Quackery and AIDS
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