FDA Press Releases

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2007

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

December 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 Warns Consumers Not to Use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai Chaojimengnan) (Dec. 28)
• FDA Approves Voluven to Treat Serious Blood Volume Loss following Surgery (Dec. 27)
• FDA Warns About Potential for Botulism in Canned Green Beans (Dec. 21)
• FDA Develops New Tools to Further Improve the Security of Food and Cosmetics (Dec. 21)
• FDA Issues Second Safety Warning on Fentanyl Skin Patch (Dec. 21)
• FDA Investigation Leads to Prison Sentence for Woman Who Claimed to Cure 'Lou Gehrig's Disease' (Dec. 19)
• FDA Grants Tentative Approval to First Generic for Antiretroviral Viread (Dec. 18)
• FDA Mandates New Warning for Nonoxynol 9 OTC Contraceptive Products (Dec. 18)
• FDA Approves New Beta Blocker to Treat High Blood Pressure (Dec. 17)
• FDA Warns Consumers Not to Use Swad Brand Sindoor: Product Contains High Levels of Lead (Dec. 15)
• FDA Approves Kuvan for Treatment of Phenylketonuria (PKU) (Dec. 13)
• Carbamazepine Prescribing Information to Include Recommendation of Genetic Test for Patients with Asian Ancestry (Dec. 12)
• FDA's Safety Reviews of Prilosec and Nexium Find No Evidence of Increased Rates of Cardiac Events (Dec. 10)
• FDA Launches E-mail Alert Subscription Service Through Public Web Site (Dec. 3)

November 2007

• FDA Extends Comment Period for Proposed Sunscreen Rule (Nov. 27)
• FDA Approves Zyrtec for Nonprescription Use in Adults and Children (Nov. 21)
• FDA Issues Early Communication for Chantix (Nov. 20)
• FDA Approves Nexavar for Patients with Inoperable Liver Cancer (Nov. 19)
• FDA Awards Grants to Further Food Safety (Nov. 19)
• Approximately $2 Million of Potentially Harmful "Cosmetic" Eye Product Seized (Nov. 16)
• FDA Announces Board Members of Reagan-Udall Foundation (Nov. 16)
• FDA Announces Steps to Improve Advisory Committee Processes (Nov. 15)
• FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia (Nov. 14)
• FDA Approves Nonprescription Zyrtec-D for Allergies, Colds (Nov. 9)
• FDA Clears Silver-Coated Breathing Tube for Marketing (Nov. 8)
• FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents (ESAs) (Nov. 8)
• HHS Unveils Plan to Strengthen, Update Food Safety Efforts (DHHS Release, Nov. 6)
• FDA Selects Members for Risk Communication Advisory Committee (Nov. 5)
• FDA Requests Marketing Suspension of Trasylol (Nov. 5)
• FDA Requests Recall of 'True Man Sexual Energy,' 'Energy Max' Dietary Supplements (Nov. 2)
• More than $300,000 of Drugs and Dietary Supplements Seized (Nov. 1)
• FDA Says Consumers Continue to Buy Risky Drugs Online (Nov. 1)

October 2007

• FDA Approves Tasigna for Treatment of Philadelphia Chromosome Positive Chronic Myeloid Leukemia (Oct. 30)
• FDA Issues Early Communication About an Ongoing Safety Review of Aprotinin Injection (Oct. 26)
• FDA Approves Ixempra for Advanced Breast Cancer Patients (Oct. 22)
• FDA Approves Change in Storage Conditions for Humate-P (Oct. 19)
• FDA Announces Revisions to Labels for Cialis, Levitra and Viagra (Oct. 18)
• FDA Expands Age Range for Use of Bacterial Meningitis Vaccine (Oct. 18)
• FDA Approves New Drug to Treat Complicated Urinary Tract and Intra-Abdominal Infections (Oct. 17)
• FDA Provides Advice on Safe Sources of Puffer Fish (Oct. 17)
• FDA Approves New HIV Drug (Oct. 16)
  
• Gerald F. Masoudi Named FDA Chief Counsel (Oct. 16)
• Statement on Medtronic's Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads (Oct. 15)
• Approximately $71,000 of Dietary Supplements Seized at FDA Request (Oct. 12)
  
• FDA Commissioner Meets with Chinese Minister of Health and Other Senior Chinese Government Officials on Import Safety (Oct. 12)
• FDA Approves First Generic Versions of Trileptal (Oct. 9)
• FDA Seeks Nominations for Reagan-Udall Foundation (Oct. 4)
• FDA Announces Initiative to Bolster Generic Drug Program (Oct. 4)
• FDA Takes Next Step in Transformation of its Center for Drug Evaluation and Research (Oct. 4)
• FDA Acts to Ensure Thyroid Drugs Don’t Lose Potency Before Expiration Date (Oct. 3)
• FDA's Dr. Janet Woodcock Honored by Alliance for Aging Research for Improving Healthy Aging (Oct. 1)

September 2007

• FDA Approves Lamisil for Pediatric Treatment of Scalp Ringworm (Sept. 28)
• Additional Influenza Vaccine Approved for Upcoming Influenza Season (Sept. 28)
• FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products (Sept. 28)
• New Law Ensures Access to Medical Treatments and Information (HHS press release, Sept. 27, 2007)
• FDA Warns of Potential Serious Side Effects with Breakthrough Cancer Pain Drug (Sept. 26)
• Statement by FDA Commissioner Andrew C. von Eschenbach on Dr. Galson’s Appointment (Sept. 21)
• FDA Warns Consumers Not to Consume "Organic Pastures Raw Cream" (Sept. 21)
• Statement by FDA Commissioner Andrew C. von Eschenbach on Passage of FDA Amendments Act of 2007 (FDAAA) (Sept. 20)
• FDA Warns Consumers about the Risk of Cryptosporidium Illness from Baby's Bliss Gripe Water (Sept. 20)
• FDA Proposing Phase Out of CFCs in Metered-Dose Inhalers for Epinephrine (Sept. 20)
• FDA Approves Nasal Influenza Vaccine for Use in Younger Children (Sept. 19)
• FDA Appoints Coté to Head Orphan Products Development Office (Sept. 18)
• FDA Warns Procter & Gamble about Unlawful Marketing of Product for School Children (Sept. 18)
• FDA Clears for Marketing First Rapid Test to Screen for Bacterial Contamination in Blood Platelets (Sept. 18)
• FDA Clears Genetic Lab Test for Warfarin Sensitivity (Sept. 17)
• AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications (Sept. 17)
• FDA Licenses 15 New Blood Typing Tests (Sept. 14)
• FDA Approves New Uses for Evista (Sept. 14)
• Chief Counsel Leaves HHS/FDA for Private Sector (Sept. 12)
• Statement by Commissioner von Eschenbach on the Release of the Strategic Framework Document on Import Safety (Sept. 10)
• FDA Approves First Generic Versions of Coreg (Sept. 5)
• FDA Issues Warning Letter to Melanocorp, Inc. For Illegal Sale of Melanotan II (Sept. 5)
• FDA Approves Second-Generation Smallpox Vaccine (Sept. 1)

August 2007

• FDA Approves New Drug to Treat Rare Disease, Acromegaly (Aug. 30)
• FDA Approves Second West Nile Virus Screening Test for Donated Blood and Organs (Aug. 28)
• FDA Approves Human Thrombin for Topical Use in Surgery (Aug. 28)
• Mars Petcare US, Inc. Recalls Dry Dog Food (Aug. 25)
• FDA Expands Warning on Eating Raw Oysters from
  Hood Canal in Washington State (Aug. 24)
• FDA Proposes New Rule for Sunscreen Products (Aug. 23)
• FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents (Aug. 22)
• FDA Warning on Codeine Use by Nursing Mothers (Aug. 17)
• FDA Approves Updated Warfarin (Coumadin) Prescribing Information (Aug. 16)
• Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk (Aug. 14)
• Federal Court Issues Permanent Injunction Against Puerto Rico Dairies for Drug Residues Found in Cows (Aug. 14)
• 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 Takes Action Against Iowa Dairy for Illegal Drug Residues Found in Cows (Aug. 9)
• FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol (Aug. 9)
• FDA Approves Novel Antiretroviral Drug (Aug. 6)
• FDA Warns of Potential Botulism Risk from Canned French Cut Green Beans (Aug. 3)
• FDA, Defense Department Share Data to Enhance Medical Product Safety Reviews (Aug. 2)

July 2007

• FDA Announces Program to Enhance States’ Food Safety Programs (July 31)
• FDA Permits Restricted Use of Zelnorm for Qualifying Patients (July 27)
• FDA Statement on Gene Therapy Clinical Trial (July 26)
• FDA Nanotechnology Report Outlines Scientific, Regulatory Challenges (July 25)
• FDA Expands Its Nationwide Warning About the Risk of Botulism Poisoning From Certain Castleberry Food Products and Dog Food (July 21)
• FDA Issues Nationwide Warning to Consumers About Risk of Botulism Poisoning From Hot Dog Chili Sauce Marketed Under a Variety of Brand Names (July 18)
• FDA Approves First of a Kind Medical Device to Treat Cervical Degenerative Disc Disease (July 17)
• FDA Approves First Molecular-Based Lab Test to Detect Metastatic Breast Cancer (July 16)
• Update on Tainted Veggie Booty Snack Food (July 13)
• FDA Approves CustomVue Monovision LASIK (July 12)
• EFSA and FDA Strengthen Cooperation in Food Safety Science (July 2)
• FDA Finds Consumers Continue to Buy Potentially Risky Drugs Over the Internet (July 2)
• FDA Approves First Generic Versions of Lamisil Tablets (July 2)

June 2007

• FDA Warns Consumers Not to Eat Veggie Booty Snack Food (June 28)
• FDA Detains Imports of Farm-Raised Chinese Seafood (June 28)
  
• FDA Clears for Marketing First Quick Test for Malaria (June 26)
• Shelhigh Enters Consent Order with FDA (June 22)
• FDA Issues Dietary Supplements Final Rule (June 22)
• FDA Approves First Drug for Treating Fibromyalgia (June 21)
• FDA Clears 'Computerized Medication Box' for U.S. Market (June 21)
• Regulatory Cooperation Expanded (June 18)
• FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension (June 15)
• FDA Releases New Software Tool to Help Keep Food Facilities Safe from Attack (June 15)
• FDA Implementing Initiative to Reduce Tomato-Related Foodborne Illnesses (June 12)
• FDA Releases Human Tissue Task Force Report (June 12)
• FDA Science Board to Meet on June 14 (June 8)
• FDA Announces New Advisory Committee to Address Risk Communication (June 4)
• FDA Approves Continuous 7-Day Glucose Monitoring System (June 4)
  
• FDA Advises Consumers to Avoid Toothpaste From China Containing Harmful Chemical (June 1)

May 2007

• FDA Finalizes Guidances For Pandemic and Seasonal Influenza Vaccines (May 31)
• FDA Approves New Drug for Advanced Kidney Cancer (May 30)
• Tembec and Uniscope Voluntary Recall Feed Ingredients (May 30)
• Advanced Medical Optics Voluntarily Recalls Complete MoisturePlus Contact Lens Solution (May 26)
• FDA Takes Action to Stop Marketing of Unapproved Timed-Release Guaifenesin Drug Products (May 25)
• FDA Warning on Mislabeled Monkfish (May 24)
• FDA Requests Boxed Warning for Contrast Agents Used to Improve MRI Images (May 23)
• FDA Approves Contraceptive for Continuous Use (May 22)
• FDA Issues Safety Alert on Avandia (May 21)
• USDA Clears Swine for Processing (May 15)
• FDA Approves Expanded Use for Surgical Sealant (May 15)
• FDA Issues Health Risk Alert for 'True Man' and 'Energy Max' Products (May 10)
• FDA Announces Results of Investigation Into Illegal Promotion of OxyContin by The Purdue Frederick Company, Inc. (May 10)
• FDA Approves Neupro Patch for Treatment of Early Parkinson's Disease (May 9)
• FDA Clears First Respirators for Use in Public Health Medical Emergencies (May 8)
• FDA/USDA Joint News Release: Scientists Conclude Very Low Risk to Humans
  from Food Containing Melamine (May 7)
  
• FDA Advises Manufacturers to Test Glycerin for Possible Contamination (May 4)
• FDA Launches New Web Page, E-newsletter to Enhance Online Consumer Health Information (May 3)
• New Critical Path Report Highlights Research Needed to Foster Generic Drug Development (May 2)
• FDA Requests Recall of All Shelhigh Medical Devices (May 2)
• FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications (May 2)
• FDA Warns Consumers about Counterfeit Drugs from Multiple Internet Sellers (May 1)
• FDA Commissioner Announces New Food Protection Position (May 1)

April 2007

• Joint Update: FDA/USDA Trace Adulterated Animal Feed to Poultry (April 30)
• Joint Update: FDA/USDA Update on Tainted Animal Feed (April 28)
• FDA Approves Product to Treat Common Bleeding Disorder (April 27)
• FDA and USDA Determine Swine Fed Adulterated Product (April 26)
• Major Manufacturer of Unapproved and Adulterated Drugs Agrees to Stop Illegal Practices (April 25)
• FDA Approves First Generic Versions of Ambien (Zolpidem Tartrate) for the Treatment of Insomnia (April 23)
• FDA’s Update on Tainted Pet Food (April 22)
• FDA Announces Audio Broadcasts on Emerging Drug Safety Information (April 20)
• Worldwide Fish and Seafood, Inc. Enters Consent Decree with FDA (April 19)
• FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Manufacturing Violations (April 17)
• FDA Approves First U.S. Vaccine for Humans Against the Avian Influenza Virus H5N1 (April 17)
• Information on Natural Balance (April 16)
• FDA Announces Recommendations to Reauthorize Medical Device User Fee Program (April 16)
• FDA Urgently Warns Consumers about Health Risks of Potentially Contaminated Olives (April 13)
• FDA Approves Antibiotic Ointment for Children and Adults (April 13)
• FDA to Hold Public Hearing on Medication Guide Program (April 12)
• FDA Warns Consumers That Retailers May Still Have Recalled Pet Food on Shelves (April 12)
• FDA Re-Emphasizes Warnings to Consumers on Risks of Pet Turtles (April 6)
• FDA Provides Web Access to Information on Post-Approval Device Studies (April 6)
• FDA Licenses First Biologic Product to Prevent Hepatitis B Reinfection in Liver Transplant Patients (April 6)
• FDA Announces that Companies Must Stop Marketing Suppository Products Containing Trimethobenzamide (April 6)
• FDA Issues Health Hazard Alert for Pet Chews Due to Contamination with Salmonella (April 5)

March 2007

• Company Recalls Single Product, Prescription Diet m/d Feline Dry Food (March 30)
• FDA Approves First Biologic to Treat Rare Clotting Disorder (March 30)
• FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons (March 30)
  
• FDA Announces Voluntary Withdrawal of Pergolide Products (March 29)
• FDA Launches Web page Warning Against Buying Accutane And Its Generic Versions Online (March 28)
• FDA Warns Again About Arsenic in Mineral Water (March 24)
• FDA Finalizes Report on 2006 Spinach Outbreak (March 23)
• Final PDUFA Recommendations Transmitted to Congress Will Strengthen Drug Review and Drug Safety (March 23)
• FDA Proposes New, Tougher Procedures for Membership on Advisory Committees (March 21)
• Recall of Pet Foods Manufactured by Menu Foods, Inc. (March 17)
• FDA Approves First-of-its-Kind Drug to Treat Rare Blood Disorder (March 16)
• FDA Clears Rapid Test for Meningitis (March 16)
• FDA Requests Label Change for All Sleep Disorder Drug Products (March 14)
• FDA Approves Tykerb for Advanced Breast Cancer Patients (March 13)
• FDA Proposes to Allow the Use of Alternative Temperature-Indicating Devices for Processing Low-Acid Canned Foods (March 13)
• FDA Issues Final Guidance For Safe Production of Fresh-Cut Fruits And Vegetables (March 12)
• FDA Update on Peanut Butter Recall (March 9)
• FDA Strengthens Safety Information for Erythropoiesis-Stimulating Agents (ESAs) (March 9, 2007)
• FDA Warns Consumers Not to Drink "Jermuk" brand Mineral Water (March 7)
• FDA Approves New Drug Treatment for High Blood Pressure (March 6)
• FDA Investigating Norovirus Outbreak Linked to Oysters (March 2)
• FDA Approves First Fully Automated Test to Screen for West Nile Virus in Blood and Tissue Donors (March 2)
• FDA Publishes Guidance on Communication of Drug Safety Information (March 2)
  
• FDA and CDC Remind Consumers of the Dangers of Drinking Raw Milk (March 1)
• FDA Takes Action to Halt Marketing of Unapproved Ergotamine Companies Ordered to Cease Manufacturing and Distribution of Illegal Drugs to Treat Migraine Headaches(March 1)
• FDA Update on Peanut Butter Recall (March 1)

February 2007

• FDA Approves First Drug To Prevent and Treat Vomiting in Dogs (Feb. 28)
• FDA Approves New Treatment For Crohn's Disease (Feb. 27)
• FDA Clears Baxter's Modified Infusion Pump (Feb. 27)
• Holmes By-Products, Inc. Enters Consent Decree with FDA (Feb. 27)
• FDA Update on Salmonella Outbreak Linked to All Peter Pan Peanut Butter and Certain Lot Numbers of Great Value Brand Peanut Butter (Feb. 23
• FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events (February 21, 2007)
• FDA Proposes to Strengthen Label Warning for Xolair (February 21, 2007)
• FDA Warns Consumers Not to Use Certain Jars of Earth's Best: "Organic 2 Apple Peach Barley Wholesome Breakfast Baby Food" (February 16)
• Update on Salmonella Outbreak and Peter Pan Peanut Butter and Great Value Peanut Butter (February 16)
• FDA Alerts Consumers to Unsafe, Misrepresented Drugs Purchased Over the Internet (February 16)
• FDA Warns Consumers Not to Eat Certain Jars of Peter Pan Peanut Butter and Great Value Peanut Butter--Product May Be Contaminated with Salmonella (Feb. 14)
• FDA Warns Consumers Not to Use Wild Kitty Cat Food Due to Salmonella Contamination (Feb. 13)
• FDA Announces Label and Indication Changes for the Antibiotic Ketek (Feb. 12)
• FDA Clears First of Its Kind Suture Made Using DNA Technology (Feb. 12)
• FDA Clears Critical Limb-Saving Vascular Device (Feb. 9)
• Cardinal Health 303, Inc. Signs Consent Decree with FDA Agrees to Correct Manufacturing Deficiencies (Feb. 9)
• FDA Approves Orlistat for Over-the-Counter Use (Feb. 7)
• Custom Ultrasonics Signs Consent Decree (Feb. 7)
• FDA Clears Breast Cancer Specific Molecular Prognostic Test (Feb. 6)
• President’s FY 2008 Budget Advances FDA’s Public Health Goals, Including Improving Safety of Nation’s Food Supply (Feb. 5)
• FDA Approves New Product to Treat Von Willebrand Disease (Feb. 2)

January 2007

• FDA and VA to Share Information on the Safe Use of Medical Products (Jan. 30)
• FDA Reinforces Commitment to Drug Safety (Jan. 30)
• FDA Statement on Effectiveness of Newer Birth Control Pills (Jan. 23)
• FDA Commissioner Announces Important Personnel Changes (Jan. 19)
• FDA Issues Draft Guidance on License Applications for Certain Placental/Umbilical Cord Blood Products (Jan. 16)
• GE OEC Medical Systems Signs Consent Decree with FDA (Jan. 12)
• FDA and States Closer to Identifying Source of E. coli Contamination
  Associated with Illnesses at Taco John's Restaurants (Jan. 12)
• FDA Proposes Barring Certain Cattle Material From Medical Products As BSE Safeguard (Jan. 11)
• FDA Proposes New Measures to Strengthen Drug Safety Under PDUFA Reauthorized User Fee Program (Jan. 11)
• FDA Updates Health Claim for Calcium and Osteoporosis (Jan. 5)
• FDA Approves the First Drug for Obese Dogs (Jan. 5)