FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products (U. S. Food and Drug Administration)
The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies marketing unapproved prescription drug products containing hydrocodone, a narcotic widely used to treat pain and suppress coughs. The action does not affect other hydrocodone formulations, which have FDA approval.

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IBI Therapy? Cool Path? Ablation Catheter and IBI 1500T9 RF Generator
A catheter is a flexible hollow plastic tube about the thickness of a piece of spaghetti that can be placed into a body cavity. An ?ablation catheter? is a catheter used to destroy (ablate) abnormal tissue or tissue that allows a rapid heart beat to... (Approved: 3/16/2007)

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Harry and David Recalls Hearthside Soups, Southwestern Chicken Chili Mix for an Undeclared Milk Ingredient (Sept. 12)
Harry and David is recalling all Harry and David Hearthside Soups, Southwestern Chicken Chili Mix with a 8221-1 lot code. These products include: Clear plastic bags of soup mix, 12 to 16 oz. in weight. The lot code can be found on the price sticker on the bottom of the bag.

American Pie Recalls Marie Callender Turtle Pies Because of a Possible Health Risk (August 25)
The recall is being conducted as a precautionary measure. Consumption of this product may lead to gastrointestinal illness, nausea, or vomiting.

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AspenBio Pharma Reports Strong Results With Appendicitis Triage Blood Test From Large Multiple Hospital Study (Medical News Today)
AspenBio Pharma, Inc. (Nasdaq: APPY) an emerging bio pharmaceutical company dedicated to the development of novel drugs and diagnostics for animals and humans, announced strong results from the latest pre FDA multi-hospital study using its AppyScore(TM) human appendicitis screen / triage blood test. [click link for full article]

Caraco gets US FDA approval to market methimazole tabs (PharmaBiz)
Sun Pharma's US subsidiary, Caraco Pharmaceutical Laboratories Ltd. has received final approval from US FDA for the company's Abbreviated New Drug Application (ANDA) for methimazole 5 mg and 10 mg tablets.

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FDA Warns of Potential Serious Side Effects with Breakthrough Cancer Pain Drug
The Food and Drug Administration is alerting health care professionals and consumers to concerns over the use of Fentora (fentanyl buccal) tablets after recent reports of deaths and other adverse events. .

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Caraco gets FDA approval for thyroid drug (Detroit News)
Federal regulators have given final approval for Detroit-based Caraco Pharmaceutical Laboratories' Methimazole drug, the company announced today.

Report Calls for FDA Nanotech Guidance (Medical Device Link)
An FDA task force on nanotechnology recommends that the agency issue guidance on what information about nanomaterials it needs to see from medical device firms and others seeking product approvals. It does not identify a need for any new laws or regulations at this time.

Read more about FDA Approvals - Caraco gets FDA approval for thyroid drug (Detroit News) Federal

FDA Approves Nasal Influenza Vaccine for Use in Younger Children
The U.S. Food and Drug Administration today approved expanding the population for use of the nasal influenza vaccine FluMist to include children between the ages of 2 and 5.

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Bush signs FDA-overhaul measure into law (The Star-Ledger)
WASHINGTON -- The Food and Drug Administration yesterday gained broad powers to ensure the safety of prescription drugs used by millions of Americans under a bill President Bush signed into law.

FDA tells Melville tea maker to stop using stevia (Newsday)
Federal regulators have warned Melville-based food company Hain Celestial Group Inc. to stop selling certain tea flavors because they contain "an unsafe food additive."

New FDA scrutiny for old drugs (CNN Money)
In the shadow of behemoths such as Pfizer, hundreds of small companies make thousands of long-established drugs that the majors no longer bother with. Now the U.S. Food and Drug Administration is stepping up a campaign to put these medications through its costly new-drug approval process. And that could place the little guys in peril. Deborah Autor, director of the FDA's office of compliance, ...

Read more about Bush signs FDA-overhaul measure into law (The Star-Ledger) WASHINGTON --

Taro gets US FDA approval for ciclopirox topical solution (PharmaBiz)
Taro Pharmaceutical Industries Ltd. has received approvals from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Ciclopirox topical solution, 8 per cent (nail lacquer) (ciclopirox nail lacquer) and its supplemental ANDA for loratadine Syrup (Oral Suspension), 5 mg/5 mL (loratadine syrup) in a grape flavored formulation, an over-the-counter (OTC) ...

Caraco gets US FDA approval to market methimazole tabs (PharmaBiz)
Sun Pharma's US subsidiary, Caraco Pharmaceutical Laboratories Ltd. has received final approval from US FDA for the company's Abbreviated New Drug Application (ANDA) for methimazole 5 mg and 10 mg tablets.

Read more about FDA Approvals - Taro gets US FDA approval for ciclopirox topical solution (PharmaBiz)

FDA Warns Procter and Gamble about Unlawful Marketing of Product for School Children
The U.S. Food and Drug Administration today sent a warning letter to Procter and Gamble for making unlawful claims about its Vicks Early Defense Foaming Hand Sanitizer product.

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Research and Markets: Contraception Market Report 2007 (Business Wire via Yahoo! Finance)
DUBLIN, Ireland----Research and Markets has announced the addition of Contraception Market Report 2007 to their offering.

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AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications
Two U.S. Department of Health and Human Services agencies will collaborate in the most comprehensive study to date of prescription medications used to treat attention deficit hyperactivity disorder (ADHD) and the potential for increased risk of heart attack, stroke or other cardiovascular problems.

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Cadila gets US FDA approval for hydroxychloroquine sulfate tabs (PharmaBiz)
Cadila Healthcare Ltd has received an approval from the US FDA for hydroxychloroquine sulfate tablets in the strength of 200 mg. The drug falls in the DMARD (Disease Modifying Anti-Rheumatic Drug) segment and is used in the management of rheumatoid arthritis.

Taro gets US FDA approval for ciclopirox topical solution (PharmaBiz)
Taro Pharmaceutical Industries Ltd. has received approvals from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Ciclopirox topical solution, 8 per cent (nail lacquer) (ciclopirox nail lacquer) and its supplemental ANDA for loratadine Syrup (Oral Suspension), 5 mg/5 mL (loratadine syrup) in a grape flavored formulation, an over-the-counter (OTC) ...

Read more about FDA Approvals - Cadila gets US FDA approval for hydroxychloroquine sulfate tabs (PharmaBiz)

Perlane Injectable Gel
Perlane is composed of transparent, viscous gel particles of hyaluronic acid that are implanted into facial tissue to provide volume in or just under the skin to smooth wrinkles and folds, especially around the nose, mouth and under the edges of the... (Approved: 5/2/2007)

Read more about Perlane Injectable Gel Perlane is composed of transparent, viscous gel

Bodee LLC, Inc. Issues A Voluntary Nationwide Recall of All Zencore Tabs, a Product Marketed as a Dietary Supplement (August 31)
Bodee LLC is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Zencore Tabs samples found the product contains potentially harmful, undeclared ingredients.

Bravo! Issues Nationwide Recall of Select Poultry Products for Dogs and Cats (Sept. 19)
Bravo! announces a voluntary recall of select tubes of three of its poultry products for cats and dogs.

TWC Global LLC, Inc. Issues a Voluntary Nationwide Recall of Axcil and Desirin Products Marketed as Dietary Supplements (Sept. 12)
FDA found the lot of 02B07 contains 3 mg/g of sildenafil, the active ingredient of a FDA-approved drug used for ED, as well as sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

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FDA Warns Procter and Gamble about Unlawful Marketing of Product for School Children
The U.S. Food and Drug Administration today sent a warning letter to Procter and Gamble for making unlawful claims about its Vicks Early Defense Foaming Hand Sanitizer product.

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Report Calls for FDA Nanotech Guidance (Medical Device Link)
An FDA task force on nanotechnology recommends that the agency issue guidance on what information about nanomaterials it needs to see from medical device firms and others seeking product approvals. It does not identify a need for any new laws or regulations at this time.

Zydus Cadila gets FDA nod for anti-rheumatic drug (Calcutta News)
US Food and Drug Administration (FDA) has approved Zydus Cadila's anti-rheumatoid arthritis drug, hydroxychloroquine sulfate.

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FDA fails to vet many prescription drugs (CNN.com)
Every year, doctors write approximately 65 million prescriptions for drugs not yet approved by the U.S. Food and Drug Administration, the federal agency that regulates prescription drugs.

Spineology complies with FDA warning (Pioneer Press)
Spineology Inc., an Oakdale-based maker of spinal treatments, has changed marketing materials and sought a meeting with regulators after receiving a U.S. Food and Drug Administration warning letter last month saying the company was promoting a medical device for an unapproved use.

Read more about FDA fails to vet many prescription drugs (CNN.com) Every year,

Relief -- and some bitter pills (The Star-Ledger)
WASHINGTON -- The House and Senate have given final approval to far-reaching legislation broadening the Food and Drug Administration's prescription drug safety powers, providing greater disclosure of drug risks and promising the pharmaceutical industry timely reviews and approvals of new medicines.

Cadila gets US FDA approval for hydroxychloroquine sulfate tabs (PharmaBiz)
Cadila Healthcare Ltd has received an approval from the US FDA for hydroxychloroquine sulfate tablets in the strength of 200 mg. The drug falls in the DMARD (Disease Modifying Anti-Rheumatic Drug) segment and is used in the management of rheumatoid arthritis.

FDA Accepts sNDA for Expanded Use of Angiomax(R) (bivalirudin) (Business Wire via Yahoo! Finance)
PARSIPPANY, N.J.----The Medicines Company said today that the U.S. Food and Drug Administration has accepted the Company's supplemental new drug application for a modified dosing regimen of Angiomax for the treatment of acute coronary syndromes , specifically in patients with unstable angina or non-segment elevation myocardial infarction .

Read more about FDA Approvals - Relief -- and some bitter pills (The Star-Ledger) WASHINGTON --

FDA Warns Consumers about the Risk of Cryptosporidium Illness from Babys Bliss Gripe Water
The U.S. Food and Drug Administration (FDA) is warning consumers not to consume Babys Bliss Gripe Water, apple flavor, with a code of 26952V and expiration date of October 2008 (shown as 10/08 on the label), distributed by MOM Enterprises, Inc., of San Rafael, Calif.

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