FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs
The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).

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FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications
The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality).

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GTx Submits New Drug Application for Toremifene 80 mg for the Prevention of Bone Fractures in Men with Prostate Cancer ... (Centre Daily Times)
GTx, Inc. (Nasdaq: GTXI) today announced the submission of a New Drug Application with the U.S. Food and Drug Administration (FDA) for toremifene 80 mg, an oral selective estrogen receptor modulator (SERM), for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy (ADT).

FDA Advisory Committee Unanimously Recommends Approval For New Ophthalmic Product Enabled By InSite's DuraSite ... (Medical News Today)
InSite Vision Incorporated (AMEX:ISV) announced that the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to recommend approval of Bausch & Lomb's besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis, a product that utilizes InSite Vision's DuraSite patented drug delivery system.

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Pro-Pharmaceuticals Provides Year-End Update (Centre Daily Times)
Pro-Pharmaceuticals, Inc. (the Company ) (NYSE Alternext US: PRW) , today provided an update regarding the company s proposed rights offering, pre-New Drug Application (NDA) filing and related meeting with the U.S. Food and Drug Administration (FDA) regarding the company s lead product candidate DAVANAT , NYSE Alternext US stock listing, and cash saving initiatives.

FDA Advisory Committee Unanimously Recommends Approval For New Ophthalmic Product Enabled By InSite's DuraSite ... (Medical News Today)
InSite Vision Incorporated (AMEX:ISV) announced that the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to recommend approval of Bausch & Lomb's besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis, a product that utilizes InSite Vision's DuraSite patented drug delivery system.

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Cardium Reports on Exchange Listing With NYSE Alternext US (PR Newswire via Yahoo! Finance)
Cardium Therapeutics reported notification from the staff of its current listing exchange indicating that the company is currently considered to be noncompliant with certain listing requirements of the NYSE Alternext US LLC .

FDA Advisory Committee Unanimously Recommends Approval For New Ophthalmic Product Enabled By InSite's DuraSite ... (Medical News Today)
InSite Vision Incorporated (AMEX:ISV) announced that the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to recommend approval of Bausch & Lomb's besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis, a product that utilizes InSite Vision's DuraSite patented drug delivery system.

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Lannett gets US FDA nod for Ursodiol 300 mg caps (PharmaBiz)
Lannett Company, Inc, a manufacturer of generic pharmaceuticals, has received approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Ursodiol 300 mg capsules, the generic equivalent of Actigall marketed by Watson Pharmaceuticals.

Beckman Coulter Announces FDA Clearance Of UniCel(R) DxH 800 (Medical News Today)
Beckman Coulter, Inc. (NYSE: BEC), a leading developer, manufacturer, and marketer of products that simplify and automate complex biomedical testing, ushers in a new era of cellular analysis with the release of the UniCel(R) DxH 800 Coulter(R) Cellular Analysis System.

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FDA Obtains Injunction to Stop Production of Illegally Medicated Animal Feed
The U.S. Food and Drug Administration announced today that the District Court for the Western District of Missouri entered a Consent Decree on Dec. 15, 2008, prohibiting Milbank Mills, an animal feed mill in Chillicothe, Mo., from manufacturing, processing, or distributing medicated animal feed. Milbank Mills and its officers Edward P. Milbank and Darrell L. Allen, face these restrictions until they comply with current Good Manufacturing Practice (cGMP) requirements for medicated animal feeds.

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New Shelter Caters to Homeless Women (Santa Barbara Independent)
The Women's Free Shelter Clinic aims to comfort clients with a homey atmosphere.

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Carotid WALLSTENT® Monorail® Endoprosthesis
The Carotid WALLSTENT ® Monorail ® Endoprosthesis is an implant used to re-open narrowed (stenotic) regions of the carotid arteries in the neck which supply blood to the brain. This device consists of the stent and a stent delivery system... (Approved: 10/23/2008)

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FDA Announces Class I Recalls of Two Unapproved Devices (December 15)
The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.

Louisiana Fish Fry Products Issues Nationwide Allergy Alert on Undeclared Buttermilk in Chicken and Fish Bake Seasoned Coating Mix (December 5)
The recalled Chicken and Fish Bake was distributed nationwide in retail stores and through mail orders. The product comes in a 6 ounce bag marked with a "Best By" date from Jan 1, 2008 thru Sept. 25, 2011.

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FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A
The U.S. Food and Drug Administration today approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia.

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FDA Approves Use of Temporary Pump to Assist Heart's Right Side
The U.S. Food and Drug Administration approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart. Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart's left ventricle, which pumps oxygen-rich blood to the rest of the body. The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen.

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*vwd/BUSINESS WIRE: FDA Issues Complete Response Letter to Ipsen for Dysport^ Biologics License Application (vwd.de)
MITTEILUNG UEBERMITTELT VON BUSINESS WIRE. FUER DEN INHALT IST ALLEIN DAS BERICHTENDE UNTERNEHMEN VERANTWORTLICH.

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Vasovist (gadofosveset Trisodium) - First Imaging Agent Approved For Magnetic Resonance Angiography (MRA) In The U.S. (Medical News Today)
EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX), a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, today announced that the U.S.

Beckman Coulter Announces FDA Clearance Of UniCel(R) DxH 800 (Medical News Today)
Beckman Coulter, Inc. (NYSE: BEC), a leading developer, manufacturer, and marketer of products that simplify and automate complex biomedical testing, ushers in a new era of cellular analysis with the release of the UniCel(R) DxH 800 Coulter(R) Cellular Analysis System.

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NeurogesX Announces FDA Acceptance To Review New Drug Application For NGX-4010 To Treat Post Herpetic Neuralgia (Medical News Today)
NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) to review its investigational product candidate, NGX-4010, for the management of pain due to post-herpetic neuralgia (PHN).

VITROS(R) 3600 Immunodiagnostic System For Laboratory Diagnostics Receives 510(k) Clearance From The FDA (Medical News Today)
Ortho Clinical Diagnostics announced 510(k) clearance from the United States Food and Drug Administration (U.S. FDA) for its VITROS(R) 3600 Immunodiagnostic System. This new high-capacity immunoassay system provides laboratories with a truly innovative solution to address their quality, labor and cost challenges.

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Historic Building One Dedicated at FDA's White Oak Federal Research Center
The General Services Administration's National Capital Region (GSA/NCR), the U.S. Department of Health and Human Services (HHS), and the HHS Food and Drug Administration (FDA) today dedicated historic Building One at the White Oak Federal Research Center in Silver Spring, Md.

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FDA Announces Class I Recalls of Two Unapproved Devices
The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.

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Food safety to take backseat to economy (UPI)
WASHINGTON, Dec. 26 (UPI) -- Fixing the U.S. food system will take a backseat to bigger problems such as the failing economy and healthcare, says Sen. Dick Durbin, D-Ill.

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FDA Requires Additional Data For Seroquel XR Supplemental New Drug Application (Medical News Today)
The U.S. FDA (Food and Drug Administration) has asked AstraZeneca, the makers of Seroquel XR (quetiapine fumarate), for additional information for its extended release tablets for the treatment of MDD (Major Depressive Disorder) in adult patients. The FDA's CRL (Complete Response Letter) was sent to AstraZeneca on 24th December.

Treadmill Desks: A Healthy Alternative on the Heels of FDA Warnings of 25 Weight Loss Products (PRWeb)
25 diet products have received stern consumer warnings from the FDA for potential dangers yet a simpler, safer, more effective solution exists. (PRWeb Dec 24, 2008) Read the full story at http://www.prweb.com/releases/Treadmill_Desk/Trek_Desk/prweb1792264.htm

FDA Seeks Recall Of 25 Weight Loss Pills With Potentially Unsafe Ingredients (Medical News Today)
The Food and Drug Administration (FDA) in the United States is seeking to recall 23 different products marketed as for weight loss because they contain undeclared active pharmaceutical substances that may pose serious health risks to consumers. The products are marketed over the Internet and in retail stores, and in some cases are described as "dietary supplements" .

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Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful
A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medications.

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