FDA Approves Kuvan for Treatment of Phenylketonuria (PKU)
The U.S. Food and Drug Administration today approved Kuvan (sapropterin dihydrochloride), the first drug of its kind approved to slow the effects of a rare genetic disorder that causes mental retardation, smaller brain size, delayed speech and other neurological problems. Tetrahydrobiopterin (BH4)-responsive phenylketonuria or PKU disease occurs in one out of every 12,000 to 15,000 live births in the United States.

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Noven Announces FDA Tentative Approval of Stavzor(TM) Valproic Acid Delayed Release Capsules (Finanzen.net)
Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced that the U.S. Food and Drug Administration (FDA) has issued a tentative approval letter related to the New Drug Application (NDA) for Stavzor (valproic acid delayed release ...

Noven Announces FDA Tentative Approval of Stavzor(TM) Valproic Acid Delayed Release Capsules (wallstreet:online AG)
Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced that the U.S. Food and Drug Administration

pSivida Receives NASDAQ Notification Related to Minimum Bid Price (Finanzen.net)
pSivida Limited (NASDAQ: PSDV)(ASX: PSD)(FF: PSI), a global drug delivery company, today announced that on December 27, 2007, the Company received a letter from the NASDAQ Listing Qualifications Department notifying the Company that, ...

Read more about Noven Announces FDA Tentative Approval of Stavzor(TM) Valproic Acid Delayed

Analysts foresee more boutique drugs (AP via Yahoo! News)
There is no quick remedy for what ails the pharmaceutical industry: a tougher environment for drug approvals and a dwindling pipeline of new medications.

Drug industry shifts to niches (The Washington Times)
ASSOCIATED PRESS

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KV Pharmaceutical Company Announces NYSE Listing Extension (The San Francisco Examiner)
ST. LOUIS , Dec. 28 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company (NYSE: KVa/KVb) a fully integrated specialty pharmaceutical company that develops, manufactures, acquires and markets technology differentiated branded and generic/non-branded prescription pharmaceutical products, announced today that NYSE Regulation, Inc. has granted KV's request for a trading extension through February 15, ...

Theravance Receives Notice of Possible Telavancin Review by FDA Advisory Committee (Marketwire via Yahoo! Finance)
Theravance, Inc. today announced that it has received notice from the U.S. Food and Drug Administration that the agency's Anti-Infective Drugs Advisory Committee may soon meet to review the NDA for telavancin, a novel, bactericidal, once-daily injectable antibiotic proposed to treat complicated skin and skin structure infections caused by Gram-positive bacteria, including resistant pathogens ...

Read more about FDA Approvals - KV Pharmaceutical Company Announces NYSE Listing Extension (The San Francisco

FDA Warns Consumers Not to Use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai Chaojimengnan)
The U.S. Food and Drug Administration (FDA) is advising consumers not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular, also marketed as Shangai Chaojimengnan, products because they contain undeclared active ingredients of FDA-approved prescription drugs for erectile dysfunction.

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FDA Grants Tentative Approval to First Generic for Antiretroviral Viread
The U.S. Food and Drug Administration has issued a tentative approval for a generic version of Viread (tenofovir disoproxil fumarate), a drug for use in combination with other antiretroviral agents in the treatment of HIV.

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Health center presents trendy contraceptives (The Red and Black)
The University Health Center offers multiple birth control options, and officials say they hope to have more contraceptives. "We hope to have IUDs available early next year," said Margaret Cramer, a gynecologist at the Women's Clinic. NEW BIRTH CONTROLAll information for fees-paid students: Implanon: $691 ($602 for implant, $89 for clinic fees) Nuva Ring: $40 per monthThe intrauterine device, ...

Metro Communities (The Des Moines Register)
DES MOINES

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Strativa Pharmaceuticals, the Proprietary Products Division of Par Pharmaceutical, Provides an Update on Development ... (The San Francisco Examiner)
WOODCLIFF LAKE, N.J. ( Map ) - WOODCLIFF LAKE, N.J., Dec. 28 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. (NYSE: PRX ) today provided an update on the development status of its three, in-licensed, proprietary pipeline products: pafuramidine, Loramyc(R) (miconazole Lauriad(R)), and Zensana(TM) (ondansetron).

'Optical Mammogram' Could Be Major Step Forward in Battle To Detect Breast Cancer (Local Tech Wire)
CHARLOTTE Editor's note: 'Charlotte Beat' will appear every Wednesday, focusing on an entrepreneur or company having an impact on the region's high-tech economy.

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FDA Launches E-mail Alert Subscription Service Through Public Web Site
The U.S. Food and Drug Administration today announced a new e-mail service that alerts subscribers whenever information is updated on certain FDA Web pages.

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Theravance Says FDA to Review Telavancin (AP via Yahoo! Finance)
Theravance Inc. said Thursday a Food and Drug Administration committee may meet soon to review telavancin, the company's once-daily injectable antibiotic for the treatment of skin infections caused by "superbug "bacteria.

Commissioner supports FDA labeling standards (News Democrat & Leader)
Kentucky consumers are increasingly aware of where and how their food is being produced. Kentucky s dairy industry assures consumers that the dairy products they purchase are safe, are of the highest quality, and also labeled correctly to meet federal Food and Drug Administration standards.

Tech Sector Outlook 2008, Part 1 (LinuxInsider.com)
Technology stocks have had a nice run in 2007, largely thanks to healthy demand for PCs with new software products, and exciting new gadgets like Apple's iPhone. The sector moved up in the first half of 2007, then retreated during the summer and autumn, along with many other sectors, amid worries about the U.S. economy caused by the subprime mortgage meltdown.

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INRange Remote Medication Management System
The INRange Remote Medication Management System is composed of clinical and communications software, a medication delivery unit, and medication packaging. The system is intended for use under the supervision of a licensed healthcare practitioner to... (Approved: 6/13/2007)

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Top Line Specialty Produce Recalls Green Paradise Basil Because of Possible Health Risk (Dec. 19)
The recalled Green Paradise Basil was distributed to Food Service Distributors through direct shipping on 12/06/2007 in Southern California, Illinois and Texas.

New Era Canning Company Recalls Canned GFS Fancy Blue Lake Cut Green Beans Because of Possible Health Risk (Dec. 21)
New Era Canning Company of New Era, Michigan is voluntarily recalling 171 cases/ 6 cans per case of 6 lbs. 5 oz. GFS Fancy Blue Lake Cut Green Beans, 4 Sieve, lot code 19H7FL , because they may be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death from botulism. Consumers are warned not to use the product even if it does not look or smell spoiled.

Cardinal Health Statement on Alaris Pump Module Worldwide Voluntary Recall (Dec. 21)
On Nov. 5, 2007, Cardinal Health notified customers of a voluntary recall for all Alaris Pump modules, model 8100 (formerly known as Medley Pump module), shipped prior to Sept. 27, 2007.

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First-time generics get US boost (Business Standard India)
Indian pharmaceutical companies led by Ranbaxy Laboratories have bagged 20 first-time generic approvals from the US Food and Drug Administration (FDA) in the eleven months from January to November this year, which constitutes about a quarter of the total 81 approvals given in this period.

Strativa Pharmaceuticals, the Proprietary Products Division of Par Pharmaceutical, Provides an Update on Development ... (Centre Daily Times)
Par Pharmaceutical Companies, Inc. (NYSE: PRX) today provided an update on the development status of its three, in-licensed, proprietary pipeline products: pafuramidine, Loramyc(R) (miconazole Lauriad(R)), and Zensana(TM) (ondansetron). These three products represent the current product pipeline of Strativa Pharmaceuticals, Par's proprietary products division.

Accentia Biopharmaceuticals Reports Fiscal 2007 Year-End Results; Pivotal Phase III Results Pending for SinuNase(TM) ... (Centre Daily Times)
Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) today announced that the Company has filed its Annual Report (Form 10-K) with the SEC, reporting the results of its operations for the fiscal year ended September 30, 2007.

Read more about FDA Approvals - First-time generics get US boost (Business Standard India) Indian pharmaceutical

FDA Warns Consumers Not to Use Swad Brand Sindoor
The U.S. Food and Drug Administration is warning consumers not to use 3.5 oz. packages of Swad brand sindoor, an orange or red powder used in some traditional South Asian Pacific ceremonies that is applied to the face or scalp, imported by Raja Foods LLC of Skokie, Illinois because the product contains high levels of lead. Although the product was not intended to be sold for food use, its labeling is confusing and implies that it may be used as food.

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Endo Pharmaceuticals to Develop and Commercialize Alexza's AZ-003 Staccato(R) Inhaled Fentanyl Product (Marketwire via Yahoo! Finance)
Endo Pharmaceuticals Holdings Inc., a market leader in pain management, today announced that it has entered into a license and development agreement with Alexza Pharmaceuticals, Inc. for the exclusive clinical development and commercialization rights in North America for Alexza's AZ-003 (Staccato fentanyl).

NeuroMetrix Completes the Acquisition of the Assets of EyeTel Imaging; Looks to Expand Market Opportunity for the ... (Finanzen.net)
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company advancing patient care through the development and marketing of innovative products used to diagnose and treat diseases of the nervous system, neurovascular disorders, and ...

NeuroMetrix Completes the Acquisition of the Assets of EyeTel Imaging; Looks to Expand Market Opportunity for the ... (Centre Daily Times)
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company advancing patient care through the development and marketing of innovative products used to diagnose and treat diseases of the nervous system, neurovascular disorders, and pain, announced today that it has acquired substantially all of the assets of EyeTel Imaging, Inc. ("EyeTel") and has assumed certain specified liabilities in ...

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FDA Issues Second Safety Warning on Fentanyl Skin Patch
The Food and Drug Administration today issued its second safety warning about the fentanyl transdermal system, an adhesive patch that delivers a potent pain medicine through the skin.

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Endo Pharmaceuticals to Develop and Commercialize Alexza's AZ-003 Staccato(R) Inhaled Fentanyl Product (Marketwire via Yahoo! Finance)
Endo Pharmaceuticals Holdings Inc., a market leader in pain management, today announced that it has entered into a license and development agreement with Alexza Pharmaceuticals, Inc. for the exclusive clinical development and commercialization rights in North America for Alexza's AZ-003 (Staccato fentanyl).

Noven Announces FDA Tentative Approval of Stavzor(TM) Valproic Acid Delayed Release Capsules (wallstreet:online AG)
Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced that the U.S. Food and Drug Administration

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Akorn, Inc. Announces FDA Inspection Results (Business Wire via Yahoo! Finance)
BUFFALO GROVE, Ill.----Akorn, Inc. today announced the results from the recent FDA cGMP compliance inspection of the Decatur, IL manufacturing facility. This inspection also served as a pre-approval inspection for Akorn's new lyophilization operation.

NeuroMetrix Completes the Acquisition of the Assets of EyeTel Imaging; Looks to Expand Market Opportunity for the ... (Business Wire via Yahoo! Finance)
WALTHAM, Mass.----NeuroMetrix, Inc. , a medical device company advancing patient care through the development and marketing of innovative products used to diagnose and treat diseases of the nervous system, neurovascular disorders, and pain, announced today that it has acquired substantially all of the assets of EyeTel Imaging, Inc. and has assumed certain specified liabilities in connection ...

NeuroMetrix Completes the Acquisition of the Assets of EyeTel Imaging; Looks to Expand Market Opportunity for the ... (Centre Daily Times)
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company advancing patient care through the development and marketing of innovative products used to diagnose and treat diseases of the nervous system, neurovascular disorders, and pain, announced today that it has acquired substantially all of the assets of EyeTel Imaging, Inc. ("EyeTel") and has assumed certain specified liabilities in ...

Read more about FDA Approvals - Akorn, Inc. Announces FDA Inspection Results (Business Wire via Yahoo!

FDA Approves Kuvan for Treatment of Phenylketonuria (PKU)
The U.S. Food and Drug Administration today approved Kuvan (sapropterin dihydrochloride), the first drug of its kind approved to slow the effects of a rare genetic disorder that causes mental retardation, smaller brain size, delayed speech and other neurological problems. Tetrahydrobiopterin (BH4)-responsive phenylketonuria or PKU disease occurs in one out of every 12,000 to 15,000 live births in the United States.

Read more about FDA Approves Kuvan for Treatment of Phenylketonuria (PKU) The U.S.

Long-Term Birth Control: New Implants and Patches (WebMD)
New birth control patches and implants let you prevent pregnancy for several months, even years, without thinking about it.

Advertisement starts (Tiscali)
The move gets U.S.-based Schering-Plough a near $5 billion-a-year (2.5 billion pound) business in women s health, central nervous system drugs and animal medicine, and marks the breakup of one of Europe s last hybrid chemical-pharmaceutical companies.

Metro Communities (The Altoona Herald-Mitchellville Index)
The city's Parks and Recreation Department will own and oversee operations of Elm Grove Cemetery in Bloomfield Township, effective Wednesday.

Read more about Long-Term Birth Control: New Implants and Patches (WebMD) New birth