FDA Press Releases

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2008

Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec

December 2008

• FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue (December 30)
• FDA Approves Drug for Patients with Advanced Prostate Cancer (December 29)
• FDA Approves First Imaging Agent to Enhance Scans of Blood Flow (December 24)
• FDA Warns Consumers About Tainted Weight Loss Pills (December 22) Updated!
• FDA Obtains Injunction to Stop Production of Illegally Medicated Animal Feed (December 22)
• FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer(December 19)
• Historic Building One Dedicated at FDA’s White Oak Federal Research Center (December 18)
• FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants (December 18)
• FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes (December 17)
• FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications (December 16)
• Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful (December 16)
• FDA Announces Class I Recalls of Two Unapproved Devices (December 15)
• FDA Warns Consumers and Retailers of Botulism Risk from Ungutted, Salt-Cured Alewives (Gaspereaux) Fish (December 12)
• FDA Requires New Safety Measures for Oral Sodium Phosphate Products to Reduce Risk of Acute Kidney Injury (December 11)
• FDA Education Program Wins Award (December 9)
• FDA Announces Permanent Injunction Against Wilderness Family Naturals LLC (December 9)
• FDA, EPA and USDA Conclude That Accidental Release of Genetically Engineered Cotton Poses No Safety Risk to Humans or Animals (December 3)
• FDA Announces Participants of Pilot Program for Third-Party Certification of Imported Aquacultured Shrimp (December 3)
• FDA Teams With WebMD For New Online Consumer Health Information (December 3)
• FDA Reports Significant Progress in Protecting the Food Supply (December 1)

November 2008

• FDA Approves New Drug to Alleviate Moderate to Severe Pain (November 24)
• FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid (November 20)
• FDA Approves New Drug to Treat Severe Form of Epilepsy (November 20)
• FDA Warns Public of Extortion Scam by FDA Impersonators (November 12)
• FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer (November 6)
• FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes (November 5)

October 2008

• FDA Approves Toviaz, a New Drug to Treat Overactive Bladder (October 31)
• HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief (October 29)
• FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report (October 28)
• FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs (October 28)
• FDA Approves Lung Valve to Control Some Air Leaks after Surgery (October 24)
• HHS Preparing to Open FDA Offices in China, India, Europe, and Latin America This Year (October 16)
• FDA Approves Updated Labeling for Psoriasis Drug Raptiva (October 16)
• FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals (October 15)
• FDA Licenses for Marketing New Therapy for Rare Genetic Disease (October 10)
• FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland (October 10)
• FDA Launches Food Defense Awareness Training Kit for Employees in the Food Industry (October 10)
• FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A (October 10)
• FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children (October 8)
• FDA Approves Use of Temporary Pump to Assist Heart's Right Side (October 7)
• FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration (October 7)
• FDA Detects Melamine Contamination in Flavored Drink (October 6)
• FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food (October 3)
• HHS Announces New Steps in Anthrax Preparedness (HHS release, October 1)

September 2008

• FDA Awards $5.2 Million in Grants to Further Food and Feed Safety (September 30)
• FDA Awards up to $2.5 Billion to Modernize Information Technology over Ten Years (September 30)
• FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of "Lou Gehrig's Disease" (September 29)
• FDA Updates Health Information Advisory on Melamine Contamination (September 26)
• FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain (September 23)
• FDA Updates Health Information Advisory on Melamine Contamination (September 23)
• FDA Updates Health Information Advisory on Melamine Contamination (September 20)
• FDA Proposes Label Requirements for Refused Imported Foods (September 18)
  
• FDA Issues Draft Guidance on Regulating Genetically Engineered Animals (September 18)
  
• FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India (September 16)
  
• FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers (September 12)
• FDA Approves Treatment for Rare Neurologic Disease (September 12)
• FDA Issues Health Information Advisory on Infant Formula (September 12)
• FDA: West Virginia Livestock Owner Sentenced in Criminal and Civil Contempt Case (September 11)
• FDA to Post Quarterly Report of Potential Safety Issues (September 5)
• FDA Approves DNA Test to Measure Hepatitis B Virus Levels (September 4)
• FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections (September 4)
• FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures (September 4)

August 2008

• FDA Clears Test to Help Doctors Manage Heart Transplant Patients (August 27)
• FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts (August 22)
• FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood (August 15)
• FDA Approves First Drug for Treatment of Chorea in Huntington's Disease (August 15)
• FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies (August 8)
• FDA Approves 2008-2009 Flu Vaccines (August 5)
• FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees (August 4)

July 2008

• FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample (July 31)
• FDA Extends Consumer Warning on Serrano Peppers from Mexico (July 30)
• Federal Agents Seize more than $24 Million in Unapproved New Drugs (July 30)
• FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder (July 29)
• FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley (July 28)
• U.S. Grown Jalapeño and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak (July 25)
• Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product (July 24)
  
• FDA Rule and Companion Guidance Make Early Stage Clinical Drug Development Safe and Efficient (July 18)
• FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals (July 17)
• FDA Reaches Settlement with California Hearing Device Maker (July 17)
• FDA Revises Process for Responding to Drug Applications (July 9)
• FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs (July 8)
• FDA Approves New Genetic Test for Patients with Breast Cancer (July 8)
• FDA Food Protection Plan Shows Significant Progress (July 2)
  

June 2008

• FDA Approves First Generic Risperidone to Treat Psychiatric Conditions (June 30)
• FDA Requests Seizure of Animal Food Products at PETCO Distribution Center (June 19)
• United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release, June 18)
• FDA Approves Diaphragm-Pacing Device (June 18)
• FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' (June 17)
• FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs (June 16)
• FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety (June 12)
• Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS release, June 9) [Fact Sheet]
• FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes (June 7)
• FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A (June 6)
• FDA Takes Action against Seafood Processing Company, Executives (June 6)
• FDA Announces New Labeling Changes for Regranex (June 6)
• FDA Announces Limited Return of Heartworm Drug to U.S. Market (June 5)
• FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes (June 3)

May 2008

• FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now (May 30)
• FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding (May 28)
• FDA Requests Recall of Xiadafil VIP Tabs (May 27)
• FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream (May 23)
• New Efforts to Help Improve Medical Products for Patient Safety and Quality Medical Care (DHHS, May 22)
• FDA Approves Entereg to Help Restore Bowel Function Following Surgery (May 20)
• FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. (May 16)
• FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16)
  
• FDA Takes Action against Cream Cheese Companies, Executives (May 15)
• Manufacturer Removes Remaining Stocks of Trasylol (May 14)
• FDA Approves New Formulation of Coagulation Therapy (May 9)
• FDA Approves First Generic Ropinirole (May 9)
• FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products (May 1)

April 2008

• Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction(April 30)
• FDA Embarks on Major Hiring Initiative for its Public Health Mission (April 30)
• FDA Approves Amitiza for IBS-C (April 29)
• Coronary Artery Plaque Imaging Device Cleared by FDA (April 29)
• FDA Approves Relistor for Opioid-Induced Constipation (April 24)
• FDA Orders Pet Food Maker to Obtain Emergency Operating Permit (April 24)
• FDA Proposes Recommendations for Two Animal Drug Funding Programs (April 24)
• FDA Strengthens Safeguards for Consumers of Beef (April 23)
• FDA Clears Glove Made from New Type of Latex (April 23)
• FDA Approves Cimzia to Treat Crohn's Disease (Apr. 22)
• FDA Approves First Compact Heart Assist Device (April 21)
• Salmonella Illnesses in Multiple States may be Linked to Recently Recalled Cereal (April 12)
• FDA Finds Hazardous Levels of Selenium in Samples of "Total Body Formula" and"Total Body Mega Formula" (April 9)
• Federal Authorities Seize More Than $100,000 of Unapproved Drugs Marketed as "Natural Supplements" (April 9)
• FDA Appoints Dr. Frank M. Torti to Senior Leadership Position (April 9)
• Federal Agents Seize Nearly $1.3 Million of Illegal Dietary Supplements (April 4)
• FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus (April 3)

March 2008

• FDA Seeks Civil Penalties from Calif. Device Maker (March 28)
• FDA Warns Consumers about "Total Body Formula" and "Total Body Mega Formula" (March 27)
• FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics (March 27)
• FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries (March 26)
• FDA Warns Consumers Not to Use "Blue Steel" and "Hero" Products (March 25)
• FDA Warns of Salmonella Risk with Cantaloupes from Agropecuaria Montelibano (March 22)
• FDA Approves New Medical Adhesive to Treat Burn Patients (March 19)
• FDA Takes Next Step in Establishing Overseas Presence (March 14)
  
• FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine
  Containing Hydrocodone (March 11)
• FDA Names Permanent Director for Center for Drug Evaluation and Research (March 10)
• FDA Warns Companies Importing and Marketing Drugs Over the Internet that Fraudulently Claim to Prevent and Treat STDs (March 6)

February 2008

• FDA Approves Nexium for Use in Children Ages 1-11 Years (Feb. 28)
• FDA Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes (Feb. 27)
• FDA Announces Permanent Injunction against Food Companies, Executives (Feb. 22)
• FDA Licenses New Hemophilia Treatment (Feb. 21)
• FDA Proposes Guidance for Dissemination of Information on Unapproved Uses of Medical Products (Feb. 15)
• Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions (Feb. 11)
  
• FDA Notifies Public of Adverse Reactions Linked to Botox Use (Feb. 8)
• New Era Canning Company Expands Nationwide Recall (Feb. 7)
  
• FDA Clears for Market First Decellularized Heart Valve (Feb. 7)
• Generic Fosamax Approved (Feb. 6)
• FDA Investigation Leads to Several Indictments for Importing Contaminated Ingredients Used in Pet Food (Feb. 6)
  
• FDA Takes Action to Stop the Marketing of Unapproved Injectable Drugs Containing Colchicine (Feb. 6)
• FDA Advises Seafood Processors About Ciguatera Fish Poisoning in the Northern Gulf of Mexico Near the Flower Garden Banks National Marine Sanctuary (Feb. 5)
• President's FY 2009 Budget Advances Food and Medical Product Safety, and the Safety of FDA-Regulated Imports (Feb. 4)
• FDA Issues Public Health Advisory on Chantix (Feb. 1)
• FDA Approves Drug-Eluting Stent for Clogged Heart Arteries (Feb. 1)

January 2008

• FDA Alerts Health Care Providers to Risk of Suicidal Thoughts and Behavior with Antiepileptic Medications (Jan. 31)
• FDA Warns Public of Contaminated Syringes (Jan. 25)
• FDA Issues Early Communication about an Ongoing Review of Vytorin (Jan. 25)
• FDA Approves New HIV Drug After Priority Review (Jan. 18)
• FDA Warns Public of Possible Botulism Risk (Jan. 18)
• FDA Approves Update to Label on Birth Control Patch (Jan. 18)
• FDA Clears for Marketing Real-Time Test for Respiratory Viruses (Jan. 18)
• FDA Releases Recommendations Regarding Use of Over-the-Counter Cough and Cold Products (Jan. 17)
• FDA Approves Sealant to Control Bleeding During Surgery (Jan. 16)
• FDA Issues Documents on the Safety of Food from Animal Clones (Jan. 15)
• FDA Approves Tysabri to Treat Moderate-to-Severe Crohn's Disease (Jan. 14)
• FDA Approves New Genetic Test for Breast Cancer Patients (Jan. 14)
• FDA Licenses 14 New Blood-Typing Tests (Jan. 11)
• FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs (Jan. 9)
• FDA Commissioner Names Directors to Food Safety and Veterinary Centers (Jan. 4)
• FDA Clears First Test Designed to Detect and Identify 12 Respiratory Viruses from Single Sample (Jan. 3)
• FDA Receives New Data on Risks of Anemia Drugs (Jan. 3)
• FDA Clears First Quick Test For Drug-Resistant Staph Infections (Jan. 2)