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FDA Warns Consumers Not to Use Blue Steel and Hero


FDA Warns Consumers Not to Use Blue Steel and Hero Products
These products are promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement.

New Davenport health clinic unveiled; promotes responsible family planning (Quad-City


New Davenport health clinic unveiled; promotes responsible family planning (Quad-City Times)
A new clinic in the heart of Davenport aims to promote responsible family planning methods as part of the statewide Iowa Initiative, which is geared toward reducing the number of unintended pregnancies in all 99 counties.

REALIZE™ Band The REALIZE? Band is a surgically implanted device


REALIZE™ Band
The REALIZE? Band is a surgically implanted device used to help a person lose weight. The REALIZE? Band consists of a silicone band, tubing, and an injection port. (Approved: 9/28/2007)

Bounty Fresh, LLC. Recalls Cantaloupe Because of Possible Health Risk


Bounty Fresh, LLC. Recalls Cantaloupe Because of Possible Health Risk (March 27)
The recalled product was distributed nationwide to wholesalers and grocery stores. Whole cantaloupe fruits subject to this recall are packed three melons in a sleeve under the brand "Chestnut Hill Farms" and one melon per sleeve under the "Perfect Melon" brand. Individual melons are not labeled, but sleeves contain tags that say either "Perfect Melon" (one count) or "Chestnut Hill Farms" (3 count). Whole cantaloupe fruits subject to this recall were sold in boxes marked with the following text: "Cantaloupe, "Chestnut Hill Farms" (3 count) or "Perfect Melon" (one count), Produce of Honduras, Grown, Packed and Shipped by Agropecuaria Montelibano, San Lorenzo, Valle, Honduras". All boxes also contain the Chestnut Hill Farms logo.

T.M. Kovacevich International, Inc. Recalls Cantaloupe Because of Possible Health Risk (March 25)
T.M. Kovacevich International, Inc. of Philadelphia, PA is recalling cantaloupes which it purchased from Agropecuaria Montelibano, a Honduran grower and packer, because the U.S. Food and Drug Administration ('FDA') has determined, based on current information, that cantaloupe fruit from this company has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Simply Fresh Fruit Announces Nationwide Recall of Some Fresh Cut Fruit Products Containing Cantaloupe Due to Possible Salmonella Contamination (March 27)
Simply Fresh Fruit, of Los Angeles, California is recalling selected fresh cut fruit products which may contain cantaloupe which has the potential to be contaminated with Salmonella.

FDA Approvals - FDA To Review Safety Of GSK, BMS Antiretrovirals Abacavir, Didanosine


FDA To Review Safety Of GSK, BMS Antiretrovirals Abacavir, Didanosine (Medical News Today)
FDA on Thursday announced that it will review the safety of GlaxoSmithKline's antiretroviral drug abacavir and Bristol-Myers Squibb's antiretroviral didanosine, Reuters reports (Richwine, Reuters, 3/27).

FDA deadlines may compromise drug safety by rushing approval (News-Medical-Net)
Many medications are approved by the U.S. Food and Drug Administration on the brink of congressionally mandated deadlines, and those drugs are more likely to face later regulatory intervention than those approved with greater deliberation, researchers at Harvard University have found.

FDA Approvals - FDA Rushed To Approve New Drugs. Are Consumers at Risk?


FDA Rushed To Approve New Drugs. Are Consumers at Risk? (First Coast News)
A Harvard study out Wednesday suggests when the FDA rushes drugs to market, those drugs are more likely to be recalled or re-labeled. The FDA is under tremendous pressure to get life-saving drugs out there so patients can use them.

Taro Receives FDA Approval For Ondansetron Hydrochloride Injection USP, 2 Mg/mL ANDA (Medical News Today)
Taro Pharmaceutical Industries Ltd. ("Taro," the "Company," Pink Sheets: TAROF) reported that it has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Ondansetron Hydrochloride Injection USP, 2 mg/mL ("Ondansetron Injection").

Ethicon Endo-Surgery Submits Application to FDA for Approval of the SEDASYS(TM) System - the First Computer-Assisted ... (The San Francisco Examiner)
CINCINNATI , March 27 /PRNewswire/ -- Ethicon Endo-Surgery announced today that the company has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the SEDASYS(TM) System, the first computer-assisted personalized sedation (CAPS) system.

FDA Approves New Medical Adhesive to Treat Burn Patients The


FDA Approves New Medical Adhesive to Treat Burn Patients
The U.S. Food and Drug Administration today approved a new medical adhesive (a fibrin sealant) called Artiss for use in attaching skin grafts onto burn patients.

FDA Approves New Orphan Drug for Treatment of Rare Inflammatory


FDA Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes
The U.S. Food and Drug Administration today approved a drug to help ease the suffering faced by those with certain chronic inflammatory diseases. Arcalyst (rilonacept, an Interleukin-1 blocker) is now approved for the long term treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS) disorders: Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

Pilgrim Software Announces Round III of its Regulatory Workshop Series:


Pilgrim Software Announces Round III of its Regulatory Workshop Series: ``Knock Out Non-Compliance'' (Business Wire via Yahoo! Finance)
TAMPA, Fla.----Pilgrim Software, Inc., a world-leading provider of Enterprise Compliance and Quality Management software solutions, today announced the dates and locations of Round Three of "Knock Out Non-Compliance," its nationwide quality systems workshops tour.

FDA Approvals - Amrubicin(R) Receives FDA Orphan Drug Designation For The Treatment Of


Amrubicin(R) Receives FDA Orphan Drug Designation For The Treatment Of Small Cell Lung Cancer (Medical News Today)
Celgene Corporation (NASDAQ: CELG) announced that Amrubicin has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer.

FDA Investigates Safety Of Asthma Drug Singulair (Medical News Today)
The US Food and Drug Administration (FDA) is reviewing the safety of Merck & Co's anti-asthma drug Singulair (montelukast) following reports querying a potential link between the drug's use and changes to behaviour and mood, suicide, and suicidal thinking and behaviour.

ARCALYST(TM), First And Only FDA-approved Treatment For Cryopyrin-Associated Periodic Syndromes (CAPS), Now Available ... (Medical News Today)
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced ARCALYST (rilonacept) Injection for Subcutaneous Use is now available for prescription in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older.

FDA Approvals - FDA Rushed To Approve New Drugs. Are Consumers at Risk?


FDA Rushed To Approve New Drugs. Are Consumers at Risk? (First Coast News)
A Harvard study out Wednesday suggests when the FDA rushes drugs to market, those drugs are more likely to be recalled or re-labeled. The FDA is under tremendous pressure to get life-saving drugs out there so patients can use them.

ARCALYST(TM), First And Only FDA-approved Treatment For Cryopyrin-Associated Periodic Syndromes (CAPS), Now Available ... (Medical News Today)
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced ARCALYST (rilonacept) Injection for Subcutaneous Use is now available for prescription in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older.

FDA Approves Nexium for Use in Children Ages 1-11 Years


FDA Approves Nexium for Use in Children Ages 1-11 Years
The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children 1-11 years old compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age.

FDA Names Permanent Director for Center for Drug Evaluation and


FDA Names Permanent Director for Center for Drug Evaluation and Research
Commissioner of Food and Drugs Dr. Andrew C. von Eschenbach today announced, after a national search, the appointment of Janet Woodcock, M.D., as director of the agency's Center for Drug Evaluation and Research (CDER).

New Davenport health clinic unveiled; promotes responsible family planning (Quad-City


New Davenport health clinic unveiled; promotes responsible family planning (Quad-City Times)
A new clinic in the heart of Davenport aims to promote responsible family planning methods as part of the statewide Iowa Initiative, which is geared toward reducing the number of unintended pregnancies in all 99 counties.

FDA Approves Nexium for Use in Children Ages 1-11 Years


FDA Approves Nexium for Use in Children Ages 1-11 Years
The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children 1-11 years old compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age.

ARCHITECT CORE-M The ARCHITECT CORE-M is a lab test


ARCHITECT CORE-M
The ARCHITECT CORE-M is a lab test used to detect antibodies associated with hepatitis B (HBV) infection. ARCHITECT CORE-M Reagent Kit, Calibrators, and Controls are used to detect antibodies associated with HBV infection. (Approved: 11/6/2007)

Bounty Fresh, LLC. Recalls Cantaloupe Because of Possible Health Risk


Bounty Fresh, LLC. Recalls Cantaloupe Because of Possible Health Risk (March 27)
The recalled product was distributed nationwide to wholesalers and grocery stores. Whole cantaloupe fruits subject to this recall are packed three melons in a sleeve under the brand "Chestnut Hill Farms" and one melon per sleeve under the "Perfect Melon" brand. Individual melons are not labeled, but sleeves contain tags that say either "Perfect Melon" (one count) or "Chestnut Hill Farms" (3 count). Whole cantaloupe fruits subject to this recall were sold in boxes marked with the following text: "Cantaloupe, "Chestnut Hill Farms" (3 count) or "Perfect Melon" (one count), Produce of Honduras, Grown, Packed and Shipped by Agropecuaria Montelibano, San Lorenzo, Valle, Honduras". All boxes also contain the Chestnut Hill Farms logo.

B. Braun's Supplier Recall of Heparin API Prompts Voluntary Recall of Heparin Solutions (March 21)
B. Braun Medical Inc. was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API).

Pilgrim Software Announces Round III of its Regulatory Workshop Series:


Pilgrim Software Announces Round III of its Regulatory Workshop Series: ``Knock Out Non-Compliance'' (Business Wire via Yahoo! Finance)
TAMPA, Fla.----Pilgrim Software, Inc., a world-leading provider of Enterprise Compliance and Quality Management software solutions, today announced the dates and locations of Round Three of "Knock Out Non-Compliance," its nationwide quality systems workshops tour.

Bioscience Company Chooses Microsoft Dynamics AX to Improve Support for Compliance With Industry Rules (The San Francisco Examiner)
REDMOND, Wash. ( Map ) - REDMOND, Wash., March 25 /PRNewswire-FirstCall/ -- Microsoft Corp. today announced that PURE Bioscience has selected Microsoft Dynamics AX 4.0 to speed and integrate its business processes, helping to support the company's compliance with the Sarbanes-Oxley Act and with the requirements of numerous regulatory authorities, including the Food and Drug Administration (FDA) ...

Bioscience Company Chooses Microsoft Dynamics AX to Improve Support for Compliance With Industry Rules (PR Newswire via Yahoo! Finance)
Microsoft Corp. today announced that PURE Bioscience has selected Microsoft Dynamics AX 4.0 to speed and integrate its business processes, helping to support the company's compliance with the Sarbanes-Oxley Act and with the requirements of numerous regulatory authorities, including the Food and Drug Administration and Environmental Protection Agency in the United States.

FDA Approvals - FDA Rushed To Approve New Drugs. Are Consumers at Risk?


FDA Rushed To Approve New Drugs. Are Consumers at Risk? (First Coast News)
A Harvard study out Wednesday suggests when the FDA rushes drugs to market, those drugs are more likely to be recalled or re-labeled. The FDA is under tremendous pressure to get life-saving drugs out there so patients can use them.

Ethicon Endo-Surgery Submits Application to FDA for Approval of the SEDASYS(TM) System - the First Computer-Assisted ... (The San Francisco Examiner)
CINCINNATI , March 27 /PRNewswire/ -- Ethicon Endo-Surgery announced today that the company has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the SEDASYS(TM) System, the first computer-assisted personalized sedation (CAPS) system.

FDA Approvals - FDA Deadlines May Impact Drug Safety (AP via Yahoo! Malaysia


FDA Deadlines May Impact Drug Safety (AP via Yahoo! Malaysia News)
Vioxx, Bextra, Rezulin, Baycol.

VIDEO: FDA Rushed Drugs (KALB Alexandria)
FDA rushed to approve new drugs. Are consumers at risk? Tracie Potts reports. more
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