FDA Updates its Nationwide Alert on Counterfeit One Touch Blood Glucose Test Strips
The U.S. Food and Drug Administration (FDA) is providing an update to its notifications on October 13, and October 23, 2006, alerting the public to counterfeit blood glucose test strips being sold in the US for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors.

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Adept Adhesion Reduction Solution (4% Icodextrin)
Adept Adhesion Reduction Solution (4% Icodextrin) is a pale yellow fluid that contains icodextrin. The fluid is used during or after laparoscopic gynecological surgery to separate and protect tissues and decrease the number of new adhesions after... (Approved: 7/28/2006)

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East Coast Foods Inc. Issues an Alert on Uneviscerated Fish
East Coast Foods Inc., 2723 W. 15th St. Brooklyn, N.Y., 11224, is recalling 48 cans of Kaija brand uneviscerated Herring in Special Brine. This product may be contaminated with Clostridium botulinum spores, which can cause botulism.

Farmer's Best International Issues Recall of Cantaloupes Because of Possible Health Risk
Farmer's Best International on behalf of Agroproductos San Rafael is announcing the recall of cantaloupes under the Lucia label brand because they have the potential to be contaminated with Salmonella, although no illnesses have been reported to date.

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Oscient Pharmaceuticals Amends FACTIVE License Agreement with LG Life Sciences (Business Wire via Yahoo! Finance)
WALTHAM, Mass.----Oscient Pharmaceuticals Corporation has amended its license and option agreement with LG Life Sciences, Ltd. for the Company's antibiotic product, FACTIVE tablets.

The Year in Review: Allergan (AP via Yahoo! Finance)
Allergan Inc. positioned itself as a dominant player in cosmetic surgery in 2006 when it bought Inamed Corp. earlier in the year, increasing the company's hedge against reimbursement concerns.

Bradley Pharmaceuticals Announces Launch of Authorized Generic of Pamine(R) (methscopolamine bromide) (FinanzNachrichten)
FAIRFIELD, N.J., Dec. 29 /PRNewswire-FirstCall/ -- Bradley Pharmaceuticals, ( Nachrichten ) Inc. reported today that A. Aarons, Inc., a subsidiary of Bradley Pharmaceuticals, has announced the launch of methscopolamine bromide tablets, an authorized generic of the Company's Pamine(R) tablets.

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FDA Approves Drug to Treat Cyanide Poisoning
The Food and Drug Administration (FDA) today approved Cyanokit (containing the drug hydroxocobalamin, intravenous tubing and a sterile spike for reconstituting the drug product with saline) for the treatment of known or suspected cyanide poisoning.

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Cloning policy change comes late for farmer (David Dishneau / ASSOCIATED PRESS) (The Washington Times)
HAGERSTOWN, Md. -- The financially strapped owner of two cloned dairy cows said yesterday that he is still in a bind, despite the Food and Drug Administration's decision that food from cloned animals is safe to eat.

Cloned Cow Owner s Fiscal Plight Unchanged By FDA Decision (CattleNetwork.com)
HAGERSTOWN, Md. (AP)--The financially strapped owner of two cloned dairy cows said Thursday he s still in a bind, despite the Food and Drug Administration s decision Thursday that food from cloned animals is safe to eat.

NovaDel Closes on $14 Million Financing (Business Wire via Yahoo! Finance)
FLEMINGTON, N.J.----NovaDel Pharma Inc. announced today that it has completed the previously announced sale of 9,823,983 shares of the Company's common stock to new and existing investors to raise approximately $14 million in gross proceeds in a common stock private equity offering.

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Oscient Pharmaceuticals Amends FACTIVE License Agreement with LG Life Sciences (Business Wire via Yahoo! Finance)
WALTHAM, Mass.----Oscient Pharmaceuticals Corporation has amended its license and option agreement with LG Life Sciences, Ltd. for the Company's antibiotic product, FACTIVE tablets.

NovaDel Closes on $14 Million Financing (Business Wire via Yahoo! Finance)
FLEMINGTON, N.J.----NovaDel Pharma Inc. announced today that it has completed the previously announced sale of 9,823,983 shares of the Company's common stock to new and existing investors to raise approximately $14 million in gross proceeds in a common stock private equity offering.

Bradley Pharmaceuticals Announces Launch of Authorized Generic of Pamine(R) (methscopolamine bromide) (FinanzNachrichten)
FAIRFIELD, N.J., Dec. 29 /PRNewswire-FirstCall/ -- Bradley Pharmaceuticals, ( Nachrichten ) Inc. reported today that A. Aarons, Inc., a subsidiary of Bradley Pharmaceuticals, has announced the launch of methscopolamine bromide tablets, an authorized generic of the Company's Pamine(R) tablets.

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The Year In Review: Allergan (Sharewatch)
Best known for its Botox wrinkle treatment, the Irvine, Calif.-based maker of eye care and cosmetic surgery products increased its cash-only product portfolio to account for a third of revenue during the year with such new products as wrinkle-fillers and breast implants.

Business news in brief (The Philadelphia Inquirer)
U.S. regulators have cleared six more companies to begin selling generic copies of Merck & Co. Inc.'s cholesterol drug Zocor, signaling steeper price reductions. The approvals posted on the Food and Drug Administration's Web site yesterday are in addition to those granted Teva Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd. in June when Merck's patents expired. Companies receiving ...

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UPDATE: E. coli O157:H7 Outbreak at Taco Bell Restaurants Likely Over FDA Traceback Investigation Continues
Based on a number of factors, iceberg lettuce is considered overall to be the single most likely source of the outbreak at this time.

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IT&E INTERNATIONAL and CORRELATE Announce Joint Marketing of K-Map FDA 21 CFR Part 11 Compliance Software Solution; ... (SYS-CON Media)
IT&E International(http://www.iteinternational.com), leading FDA compliance and validationconsulting organization, and Correlate (http://www.correlate.com), majorprovider of knowledge-based applications, announce a partnering agreementto provide K-Map FDA, Correlate's software solution for maximizinginformation assets.

Ortho-Clinical Diagnostics Receives FDA Approval For First Blood-Screening Test For Chagas' Disease (Medical News Today)
Ortho-Clinical Diagnostics, a Johnson & Johnson company, announced today that the U.S. Food and Drug Administration (FDA) has licensed its new test designed to screen blood donations for exposure to Chagas' disease -- a tropical, parasitic disease that originates in South America. Called the ORTHO(R) T. [click link for full article]

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FDA Proposes Labeling Changes to Over-the-Counter Pain Relievers
FDA today proposed to amend the labeling regulations on over-the-counter (OTC) Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) drug products to include important safety information regarding the potential for stomach bleeding and liver damage and when to consult a doctor.

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Abiomed to Ring NASDAQ Closing Bell, Celebrating Regulatory Progress and Global Leadership in Circulatory Care for ... (RedNova)
Abiomed, Inc. (NASDAQ: ABMD) today announced that Michael R. Minogue, Chairman, President and Chief Executive Officer, will ring the closing bell of the NASDAQ Stock Market on December 28, 2006 at 4 pm ET.

Anika Therapeutics Receives FDA Approval For Its Cosmetic Tissue Augmentation Product (Medical News Today)
Anika Therapeutics, Inc. (Nasdaq: ANIK) today announced that it has received FDA approval for its cosmetic tissue augmentation ("CTA") product. CTA is an injectable soft tissue filler for facial wrinkles, scar remediation and lip augmentation. The product is based on Anika's chemically modified hyaluronic acid (HA) proprietary technology and incorporates lidocaine, a local anesthetic. [click link ...

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AxSYM CORE-M? 2.0; AxSYM CORE-M? 2.0 Controls
This device is a laboratory test that detects antibody associated with acute or recent infection with hepatitis B virus (HBV) (IgM antibody to hepatitis B virus core antigen, IgM anti-HBc). (Approved: 8/25/2006)

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Cleugh's Frozen Foods Inc. Recalls Frozen Strawberries Sold to Jamba Juice
Cleugh's Frozen Foods Inc., Salinas, CA, a wholly-owned subsidiary of SunOpta Inc. (NASDAQ-STKL) (TSX-SOY), today announced a voluntary recall of frozen strawberries sold exclusively to Jamba Juice for use in strawberry smoothies sold in stores in Arizona, Nevada and Southern California between the period November 25, 2006 and December 1, 2006 because of a concern that they may have been contaminated with Listeria monocytogenes.

Consumer Alert: Listeria Contamination in Raw Milk
New York State Agriculture Commissioner Patrick H. Brennan today warned consumers in the Allegany County, New York area not to consume unpasteurized raw farm milk from the Gerald E. Snyder farm due to possible Listeria contamination.

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Par Pharmaceutical Receives Approval for Ondansetron Orally Disintegrating Tablets (PR Newswire via Yahoo! Finance)
Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for ondansetron orally disintegrating tablets in 4 mg and 8 mg strengths.

Ranbaxy Granted Final FDA Approval To Market Simvastatin 5, 10, 20 And 40 Mg Tablets (Medical News Today)
Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg and 40 mg in the U.S. [click link for full article]

Barr Confirms Generic Thalomid(R) Capsule, 50 mg and 100 mg Application (Boursorama)
WOODCLIFF LAKE, N.J., Dec. 26 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc. , today confirmed that it is seeking approval from the U.S. Food & Drug Administration (FDA) to manufacture and market a generic version of Celgene Corporation's Thalomid(R) (thalidomide) Capsules, 50 mg and 100 mg.

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Deputy Commissioner for Medical and Scientific Affairs to Leave FDA
Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs at the Food and Drug Administration announced today that he will leave the agency effective January 16, 2007, to return to the American Enterprise Institute, a Washington-based think tank where he was previously a Resident Fellow prior to joining FDA.

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ISTA Pharmaceuticals Submits Investigational New Drug Application For Eye Drop For The Treatment Of Allergic ... (Medical News Today)
ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), an ophthalmic pharmaceutical company, today announced it has submitted an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) for its eye drop formulation of bepotastine for the treatment of allergic conjunctivitis. ISTA intends to move bepotastine directly into Phase II/III clinical trials in the U.S. [click link ...

Pharmaceutical, Healthcare & Life Sciences (Mondaq)
12 December 2006 Article by Bryan C Diner, Anthony C Tridico PhD and John C. Stolpa, Ph.D.

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Zydus Cadila receives US FDA approval for simvastatin (PharmaBiz)
Cadila Healthcare Ltd has launched Simvastatin tablets 5 mg, 10 mg, 20 mg, 40 mg and 80 mg, in the US market on the very first day of receiving the approvals from the US FDA.

Memory Pharmaceuticals Announces Release Of Clinical Hold On MEM 3454 (Medical News Today)
Memory Pharmaceuticals Corp. (Nasdaq: MEMY) today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the investigational new drug application (IND) for MEM 3454 and has informed the Company that the clinical hold on the development of this drug candidate has been released. [click link for full article]

Pivotal Submission Data Shows Tasigna(R) Achieved Impressive Response Rates In Chronic Myeloid Leukemia Patients No ... (Medical News Today)
New clinical data presented today demonstrated that Tasigna(R) (nilotinib) eliminated or significantly reduced the presence of blood cells containing a defective chromosome in approximately half of adult patients with a form of life-threatening leukemia who developed resistance and/or intolerance to treatment with Gleevec(R) (imatinib mesylate) tablets. [click link for full article]

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Abiomed Announces FDA 510(K) Clearance for New Intra-Aortic Balloon and Development of Integrated Console, the iPulse, ... (RedNova)
Abiomed, Inc. (NASDAQ: ABMD) today announced U.S. Food and Drug Administration (FDA) clearance of its new intra-aortic balloon (IAB); an easy-to-insert, minimally invasive technology designed to enhance blood flow to the heart and other organs for patients with diminished heart function.

INVEGA(TM) Approved By FDA As New Treatment For Schizophrenia (Medical News Today)
The U.S. Food and Drug Administration (FDA) has approved INVEGA(TM) (paliperidone) Extended-Release Tablets, a new atypical antipsychotic, for the treatment of schizophrenia. [click link for full article]

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Celebrex Approved to Treat Juvenile Rheumatoid Arthritis
The U.S. Food and Drug Administration (FDA) today approved Celebrex (celecoxib) for a new use the relief of the signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) in patients two years of age and older.

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