FDA News Release Archives
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2004

November 2004

• FDA Announces Guidance for Generic Drugs (November 3)
• FDA Completes Review of Reprocessed Single Use Devices (November 2)
• FDA Warns Consumers That Actra-RX "Dietary Supplements" Promoted For Sexual Enhancement Contains Undeclared Prescription Drug Ingredient (November 2)

October 2004

• FDA Warns Consumers About Risks Associated With Unpasteurized Juice (October 29)
• FDA Approves Artificial Disc; Another Alternative to Treat Low Back Pain (October 26)
• FDA Approves New Device to Treat Uterine Fibroids (October 22)
• FDA Releases 2004 Produce Safety Action Plan (October 18)
• FDA Approves Temporary Artificial Heart (October 18)
• FDA Finds Hillestad Pharmaceuticals, USA, to be Violating Permanent Injunction Against Promoting Unapproved Drugs (October 1)

September 2004

• FDA Approves New Extended Release Pain Medication (September 24)
• FDA Clears Over-the-Counter Sale of Automatic External Defibrillator (September 16)
• FDA Approves Implanted Lens to Correct Nearsightedness (September 13)
• Fort Dodge to Comply with FDA's Request to Recall ProHeart 6 Injectable Heartworm Product from the Market Due to Serious Health Concerns (September 3)
• FDA Gives Advice to Consumers to Handle the Aftermath of Hurricane Frances (September 3)
• FDA Approves Device to Treat Thoracic Insufficiency Syndrome (September 2)

August 2004

• FDA Issues Guidance on Hospital Bed Design to Reduce Patient Entrapment (August 31)
• FDA Clears New Lab Test to Help Screen Newborn Infants for Congenital Disease (August 25, 2004)
• FDA Notifies Patients of Mammography Problems at Ecumed Health Group Facility in Hialeah, Florida (August 23)
• FDA Updates Its Review of Antidepressant Drugs in Children (August 20)
• FDA Recommended Seizure on Illegal Horse Drugs Carried Out by United States Marshals Under Court Order (August 12)
• FDA, Customs Revise Prior Notice Documents for Imported Foods (August 12)

July 2004

• FDA Warns Consumers About Counterfeit Drugs Purchased in Mexico (July 30)
• FDA Approves New Drug for Treatment of Alcoholism (July 29)
• FDA Approves Botox to Treat Severe Underarm Sweating (July 20)
• FDA Approves Software System to Help Detect Lung Nodules (July 12)
• FDA Alerts Consumers Not to Feed Infants Chinese Infant Formula (July 9)
• FDA Clears Robotic Device for Heart Surgery (July 7)
• FDA Seizes Tainted Crabmeat in Louisiana (July 7)
• FDA Supports Broader Access to Lower Priced Drugs (July 2)
• FDA Alerts Consumers About Adverse Events Associated With "Permanent Makeup" (July 2)

June 2004

• FDA Clears Medicinal Leeches for Marketing (June 28)
• FDA Seeks Public Comment Regarding Albuterol Metered Dose Inhalers Containing Ozone-Depleting Propellants (June 9)
• FDA Warns Against Women Using Unapproved Drug, Domperidone, to Increase Milk Production (June 7)
• FDA Revises Guidance on Reprocessing Single-Use Devices (June 1)

May 2004

• FDA Alerts Consumers of Recall of Certain Germack Brand Almonds Due to Potential Contamination (May 25)
• The 2004 FDA Science Forum: The Critical Path From Concept To Consumer (May 17)
• FDA Proposes Rule on "Combination" Products (May 6)
• FDA Approves Vitrase (Hyaluronidase for Injection) (May 6)

April 2004

• CBER Issues Annual Report for Fiscal Year 2003 and Outlines New Directions for 2004 (April 30)
• FDA Updates Zelnorm Labeling with New Risk Information (April 28)
• FDA Approves Apokyn for the Acute Treatment of Episodes of Immobility in Parkinson's Patients (April 21)

March 2004

• FDA Issues Public Health Advisory on Cautions for Use of Antidepressants in Adults and Children (March 22)
• FDA Approves First in a New Class of Drugs to Treat Hyperparathyroidism Associated With Renal Failure and in Patients With Parathyroid Cancer (March 8)
• FDA Plans to Evaluate Results of Women's Health Initiative Study for Estrogen-Alone Therapy (March 2)

February 2004

• FDA Approves Heart Assist Device for Children (February 26)
• Department of Justice Appeals Court Decision Regarding FDA's "Shared Exclusivity" Determination for Generic Paroxetine Hydrochloride Tablets (February 4)
• Adulterated Medical Devices Seized (February 4)

January 2004

• FDA Takes Actions Against Illegal Drug Import Operations of Expedite-Rx, SPC Global Technologies, and Employer Health Options (January 22)
• FDA Seizes Goods at Reed Creek Milling Due to Insanitary Conditions (January 8)