FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled
The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007.

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FDA Approves New Formulation of Coagulation Therapy
he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.

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Lupin gets tentative approval from FDA (Business Standard India)
Pharmaceutical major Lupin Ltd has received tentative approval for its marketing application for a generic version of Topiramate tablets in four dosages from the US drug regulator, Food and Drug Administration (FDA).

The Medicines Company Receives FDA Review Letter For Angiomax Supplemental Filing (Medical News Today)
The Medicines Company (NASDAQ: MDCO) announced receipt of a not approvable letter from the U.S. Food and Drug Administration (FDA) on a supplemental New Drug Application (sNDA) for an additional dosing regimen for Angiomax (bivalirudin) in the treatment of acute coronary syndromes (ACS) initiated in the emergency department.

Lupin gets US FDA tentative nod for topiramate pills (PharmaBiz)
Lupin Ltd. has received tentative approval for the company's abbreviated new drug application (ANDA) for topiramate tablets, 25 mg, 50 mg, 100 mg and 200 mg from the US Food and Drug Administration (US FDA).

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Wyeth Receives FDA Fast Track Designation for its 13-valent Pneumococcal Conjugate Vaccine for Infants and Toddlers (Presseportal)
Collegeville, Pennsylvania (ots/PRNewswire) - Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's investigational 13-valent ...

Pollution Firms Roll Despite Weak Growth (Investor's Business Daily via Yahoo! News)
There are a couple of reasons to assume waste collection and management stocks wouldn't be doing so well right now.

Tainted Drug Imports Set Off Warnings, Not FDA Action (Bloomberg via Yahoo! News)
May 30 (Bloomberg) -- Two Americans died and 15 suffered seizures. The suspected cause: The epilepsy medicine they depended on stopped working because of a counterfeit ingredient from overseas.

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Wyeth Receives Approvable Letter From FDA For TYGACIL For The Treatment Of Patients With Community-Acquired Pneumonia (PharmaceuticalOnline)
Wyeth Pharmaceuticals, a division of Wyeth, announced recently that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for the first-in-class antibiotic TYGACIL (tigecycline) for the treatment of adult patients with community-acquired pneumonia (CAP).

FDA Proposes New Drug Labeling Requirements Detailing Risks To Pregnant Women, Fetuses (Medical News Today)
On Wednesday, FDA released a proposed rule to require that updated safety information detailing the risks of drugs for pregnant and breastfeeding women -- as well as for fetuses and breastfed infants -- be added to drug labels, the Wall Street Journal reports. FDA began requiring information on drugs' risks for pregnant women in 1979 and has not changed the policy since then.

Wyeth Receives FDA Fast Track Designation For Its 13-Valent Pneumococcal Conjugate Vaccine For Infants And Toddlers (PharmaceuticalOnline)
Wyeth Pharmaceuticals, a division of Wyeth, recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers. Wyeth is seeking a pediatric indication for active immunization against invasive pneumococcal disease (IPD) and otitis media caused by serotypes ...

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Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction
Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc.

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Too old for the pill? (The Arizona Republic)
If you're approaching the middle years of your life, it might be time to review your choice of contraceptives. But don't be too hasty in putting them away for good.

Key Challenges and Issues facing the World Contraceptives Markets (Marketwire via Yahoo! Finance)
Reportlinker.com announces that a new market research report related to the Pharmaceutical industry is available in its catalogue.

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Talent™ Abdominal Stent Graft System
The Talent™ Abdominal Stent Graft System is used to repair aneurysms of the aorta in the abdomen (belly). An aneurysm is a diseased, weakened and bulging section of an artery wall. The Talent? Abdominal Stent Graft System is made of a fabric... (Approved: 4/15/2008)

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Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2)
Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash.

Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7)
Medtronic, Inc. announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs.

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Wyeth Receives FDA Fast Track Designation for its 13-valent Pneumococcal Conjugate Vaccine for Infants and Toddlers (PR Newswire via Yahoo! Finance)
Wyeth Pharmaceuticals, a division of Wyeth , today announced that the U.S. Food and Drug Administration has granted Fast Track designation to the Company's investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers.

Wyeth Receives Approvable Letter from FDA for TYGACIL for the Treatment of Patients with Community-Acquired Pneumonia (PR Newswire via Yahoo! Finance)
Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration has issued an approvable letter for the first-in-class antibiotic TYGACIL for the treatment of adult patients with community-acquired pneumonia .

Wyeth Receives Approvable Letter From FDA For Bazedoxifene For The Treatment Of Postmenopausal Osteoporosis (Medical News Today)
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced that the U.S. Food and Drug Administration (FDA) issued an approvable letter on May 21 for bazedoxifene, a selective estrogen receptor modulator, for the treatment of postmenopausal osteoporosis.

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FDA Approves First Generic Ropinirole
The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.

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FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding
The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.

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Watson Announces Oxybutynin Topical Gel NDA Accepted for Filing by FDA for the Treatment of Overactive Bladder (PR Newswire via Yahoo! Finance)
Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that its New Drug Application for oxybutynin chloride topical gel , has been accepted for filing by the U.S.

Wyeth Receives FDA Fast Track Designation for its 13-valent Pneumococcal Conjugate Vaccine for Infants and Toddlers (PR Newswire via Yahoo! Finance)
Wyeth Pharmaceuticals, a division of Wyeth , today announced that the U.S. Food and Drug Administration has granted Fast Track designation to the Company's investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers.

Amadeus eQCM Solution Deployed by One of the World's Leading Groups of Engineering and Construction Companies (CNW Group via Yahoo! Finance)
Amadeus International Inc. , a pioneer and leading provider of Enterprise Quality and Compliance Management software solutions, today announced that a worldwide engineering and construction company, present in a variety of sectors, as food and pharmaceutical industries, has selected Amadeus software suite, eQCM, to manage changes and document related processes.

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Watson Announces Oxybutynin Topical Gel NDA Accepted for Filing by FDA for the Treatment of Overactive Bladder (PR Newswire via Yahoo! Finance)
Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that its New Drug Application for oxybutynin chloride topical gel , has been accepted for filing by the U.S.

The Medicines Company Receives FDA Review Letter for Angiomax Supplemental Filing (Business Wire via Yahoo! Finance)
PARSIPPANY, N.J.----The Medicines Company announced receipt of a not approvable letter from the U.S. Food and Drug Administration on a supplemental New Drug Application for an additional dosing regimen for Angiomax in the treatment of acute coronary syndromes initiated in the emergency department.

LDR Spine has received FDA clearance for a partial vertebral body replacement device, the (Medical Device Link)
Austin Business Journal reports. The ROI-T device has a shape that conforms to the anterior vertebral body. But it is thin and its end is tapered, so it can be implanted in a minimally invasive procedure. The company says more new product approvals should come by the end of the year.

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Editorials Address Legislation That Would Increase FDA Funding For Foreign Inspections (Medical News Today)
Two newspapers recently published editorials addressing legislation approved by the Senate Appropriations Committee that would provide an additional $275 million to help FDA improve inspections of imported food and drugs.

Wyeth Receives Approvable Letter From FDA For Bazedoxifene For The Treatment Of Postmenopausal Osteoporosis (Medical News Today)
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced that the U.S. Food and Drug Administration (FDA) issued an approvable letter on May 21 for bazedoxifene, a selective estrogen receptor modulator, for the treatment of postmenopausal osteoporosis.

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Manufacturer Removes Remaining Stocks of Trasylol
Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician s stock. The FDA will work with Bayer to ensure a smooth and complete process.

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FDA Approves First Generic Ropinirole
The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.

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Too old for the pill? (The Arizona Republic)
If you're approaching the middle years of your life, it might be time to review your choice of contraceptives. But don't be too hasty in putting them away for good.

Key Challenges and Issues facing the World Contraceptives Markets (Marketwire via Yahoo! Finance)
Reportlinker.com announces that a new market research report related to the Pharmaceutical industry is available in its catalogue.

Read more about Too old for the pill? (The Arizona Republic) If you're

FreeStyle Navigator® Continuous Glucose Monitoring System
The FreeStyle Navigator Glucose Monitoring System is a glucose sensor that reports glucose values continuously for up to 120 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels in adults, age 18 and... (Approved: 3/12/2008)

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Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6)
Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution.

FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16)
The U.S. Food and Drug Administration directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007.

Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled
The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007.

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