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FDA Issues Guidance for Food Manufacturers on Use of Peanut-Derived


FDA Issues Guidance for Food Manufacturers on Use of Peanut-Derived Product
The U.S. Food and Drug Administration recommends that manufacturers obtain any peanut-derived ingredient only from suppliers who use production processes that have been demonstrated to adequately reduce the presence of Salmonella species (Salmonella spp.), or that they ensure that their own manufacturing process would adequately reduce the presence of Salmonella species.

Wyeth Submits Marketing Application to FDA for its 13-Valent Vaccine


Wyeth Submits Marketing Application to FDA for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in ... (PR Newswire via Yahoo! Finance)
Candidate vaccine designed to protect against the 13 most prevalent serotypes associated with pneumococcal disease -

FDA OKs new Japanese encephalitis vaccine (UPI)
WASHINGTON, March 31 (UPI) -- The U.S. Food and Drug Administration has approved Ixiaro, a vaccine designed to prevent Japanese encephalitis.

Wyeth Submits Marketing Application to FDA for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in ... (PR Newswire via Yahoo! Finance)
Wyeth Pharmaceuticals, a division of Wyeth , announced today that it has submitted a Biologic License Application to the U.S. Food and Drug Administration for Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM Protein).

FDA Approvals - Afinitor(R) Approved In US As First Treatment For Patients With


Afinitor(R) Approved In US As First Treatment For Patients With Advanced Kidney Cancer After Failure Of Either ... (Medical News Today)
Novartis announced that Afinitor(R) (everolimus) tablets has been approved by the US Food and Drug Administration (FDA) for patients with advanced renal cell carcinoma (RCC) after failure of treatment with Sutent(R) (sunitinib) or Nexavar(R) (sorafenib).

US Salmonella Suspicion Prompts Recall Of 1 Million Pounds Of Pistachios (Medical News Today)
The US Food and Drug Administration (FDA) alerted consumers on Monday that together with the California Department of Public Health (CDPH), they are investigating Salmonella contamination in pistachio products made at a Californian plant and that the producer is voluntarily recalling about 1 million pounds of pistachio products.

FDA Approvals - Sagent Pharmaceuticals Announces U.S. FDA Approval Of Azithromycin For Injection


Sagent Pharmaceuticals Announces U.S. FDA Approval Of Azithromycin For Injection (Medical News Today)
Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, announced U.S. Food and Drug Administration (FDA) approval of azithromycin for injection, a semi-synthetic, macrolide antibiotic that is used to treat a wide variety of bacterial infections. Sagent will offer azithromycin in a 500 mg vial for intravenous use.

FDA Approves Abiomed's New AB Portable Driver; Providing Patient Transport, Mobility and Ambulation without ... (Business Wire via Yahoo! Finance)
DANVERS, Mass.----Abiomed, Inc. , a leading provider of heart recovery products designed to recover hearts and eliminate in-hospital deaths from heart attacks and high risk percutaneous coronary interventions , today announced U.S.

FDA Issues Guidance for Food Manufacturers on Use of Peanut-Derived


FDA Issues Guidance for Food Manufacturers on Use of Peanut-Derived Product
The U.S. Food and Drug Administration recommends that manufacturers obtain any peanut-derived ingredient only from suppliers who use production processes that have been demonstrated to adequately reduce the presence of Salmonella species (Salmonella spp.), or that they ensure that their own manufacturing process would adequately reduce the presence of Salmonella species.

Doctor discusses birth control options (Asheville Citizen-Times) HENDERSONVILLE This


Doctor discusses birth control options (Asheville Citizen-Times)
HENDERSONVILLE This week, Dr. Maridee Spearman of Pardee OB/GYN Associates in Hendersonville, discusses the variety of birth control options available for women.

Merck, Shering-Plough Merge in $41 Billion Big Pharma Deal (wowOwow)
Drug maker giants Merck Co. and Schering-Plough Corp. read more

Abortion foes upset with Brownback for supporting Sebelius' HHS nomination (Lawrence Journal-World)
Some abortion opponents are upset that Sen. Sam Brownback is supporting Kansas Gov. Kathleen Sebelius nomination as U.S. secretary of health and human services.

TECNIS Multifocal Foldable Silicone and Acrylic Intraocular Lenses The TECNIS


TECNIS Multifocal Foldable Silicone and Acrylic Intraocular Lenses
The TECNIS Multifocal Foldable Intraocular Lens is a plastic lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. (Approved: 1/16/2009)

Mellace Family Brands, Inc. Recalls Peanut Products Because of Possible


Mellace Family Brands, Inc. Recalls Peanut Products Because of Possible Health Risk (March 19)
Mellace Family Brands, Inc. of Carlsbad, California, announced a voluntary recall of peanut products. This is a precautionary measure resulting from the PCA (Peanut Corporation of America) expanded recall for all products that have the potential to be contaminated with Salmonella.

The Georgia Nut Company Issues Voluntary Recall of Certain Snack Products Containing Shelled Pistachio Nuts Because of Possible Health Risk (March 25)
The Georgia Nut Company announced today a voluntary recall of certain bulk wholesale and retail products containing shelled pistachio nuts that have the potential to be contaminated with the Salmonella organism. The Company said it identified the potential as a result of a rigorous sampling and testing regimen it conducted with respect to shelled pistachios provided by a third-party supplier.

FDA Warns Consumers About Potentially Contaminated Cheese The U.S. Food


FDA Warns Consumers About Potentially Contaminated Cheese
The U.S. Food and Drug Administration is warning consumers not to eat Queso Fresco Fresh Cheese Mexican style soft cheese (two specific lots) or any Queso Cotija Molido Mexican style grated cheese manufactured and distributed by Peregrina Cheese Corp. of New York City. These products could be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in pregnant women, young children, frail or elderly people, and others with weakened immune systems.

FDA Takes Action Against KV Pharmaceutical Company The FDA announced


FDA Takes Action Against KV Pharmaceutical Company
The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA's current Good Manufacturing Practice (cGMP) and new drug approval requirements for five years.

FDA Approvals - Editorials Respond To Court Ruling That FDA Actions On Plan


Editorials Respond To Court Ruling That FDA Actions On Plan B Contraceptive Tainted By Politics (Medical News Today)
Two newspapers published editorials in response to a federal judge's recent order that FDA reconsider age restrictions on nonprescription sales of the emergency contraceptive Plan B and that FDA allow nonprescription sales to women ages 17 and older within 30 days. Summaries appear below.

FDA Requirements For Manufacturing PET Radiopharmaceuticals: Meeting (Medical News Today)
SNM and the International Partnership for Critical Markers of Disease (CMOD) are co-hosting an in-depth meeting on Friday, May 1, 2009, examining FDA requirements for manufacturing positron emission tomography (PET) radiopharmaceuticals. The meeting, which takes place at the Natcher Auditorium, National Institutes of Health, Bethesda, Md., is scheduled to begin at 6:10 p.m. and conclude at 9:45 p.

Physio-Control Receives FDA 510(K) Clearance For LIFEPAK(R) 15 Monitor/Defibrillator (Medical News Today)
Physio-Control, Inc., a wholly owned subsidiary of Medtronic, Inc., (NYSE: MDT) announced today it has received clearance from the U.S. Food and Drug Administration (FDA) to market the LIFEPAK 15 monitor/defibrillator within the United States. Official notification of the FDA 510(k) Premarket Notification was posted to the FDA website on March 16, 2009, and can be viewed here.

FDA Fireside Chat @ The 8th Annual MedTech Investing Conference


FDA Fireside Chat @ The 8th Annual MedTech Investing Conference May 6-7, 2009 (PR Newswire via Yahoo! Finance)
Billion Dollar Medical Device Market

Policy group says FDA needs single food safety chief (Center for Infectious Disease Research and Policy)
Mar 25, 2009 (CIDRAP News) A public health policy group today urged the government to put one person in charge of all food safety efforts at the Food and Drug Administration (FDA) as a first step toward preventing the kinds of foodborne disease outbreaks that have plagued the nation in recent years.

Established life science company chooses Gael to support Quality Management System (PRWeb via Yahoo! News)
As Document Control and Audit Management are key requirements to comply with life science industry regulations, Cambridge based medical device manufacturer, Biochrom Ltd has chosen a compliance management solution from Gael Ltd to improve the efficiency and effectiveness of the company's internal document and audit management system.

FDA Approvals - FDA questions studies of Genentech drug for cancer (The Arizona


FDA questions studies of Genentech drug for cancer (The Arizona Republic)
Regulators say it's unclear whether the blockbuster brain cancer drug Avastin is effective.

FDA questions studies of Genentech drug for cancer (AP via Yahoo! News)
Federal health regulators said Friday it's unclear whether Genentech's blockbuster cancer drug Avastin significantly shrinks the deadliest type of brain tumor.

Sagent Pharmaceuticals Announces U.S. FDA Approval Of Azithromycin For Injection (Medical News Today)
Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, announced U.S. Food and Drug Administration (FDA) approval of azithromycin for injection, a semi-synthetic, macrolide antibiotic that is used to treat a wide variety of bacterial infections. Sagent will offer azithromycin in a 500 mg vial for intravenous use.

FDA Approvals - FDA questions studies of Genentech drug for cancer (The Arizona


FDA questions studies of Genentech drug for cancer (The Arizona Republic)
Regulators say it's unclear whether the blockbuster brain cancer drug Avastin is effective.

FDA questions studies of Genentech drug for cancer (San Francisco Chronicle)
Federal health regulators said Friday it's unclear whether Genentech's blockbuster cancer drug Avastin significantly shrinks the deadliest type of brain tumor. The Food and Drug Administration is reviewing the company's drug for patients with recurring...

Editorials Respond To Court Ruling That FDA Actions On Plan B Contraceptive Tainted By Politics (Medical News Today)
Two newspapers published editorials in response to a federal judge's recent order that FDA reconsider age restrictions on nonprescription sales of the emergency contraceptive Plan B and that FDA allow nonprescription sales to women ages 17 and older within 30 days. Summaries appear below.

FDA Issues Guidance for Food Manufacturers on Use of Peanut-Derived


FDA Issues Guidance for Food Manufacturers on Use of Peanut-Derived Product
The U.S. Food and Drug Administration recommends that manufacturers obtain any peanut-derived ingredient only from suppliers who use production processes that have been demonstrated to adequately reduce the presence of Salmonella species (Salmonella spp.), or that they ensure that their own manufacturing process would adequately reduce the presence of Salmonella species.

FDA Warns Against Consuming Peanuts and Peanut Products Sold by


FDA Warns Against Consuming Peanuts and Peanut Products Sold by Westco Fruit and Nuts Inc.
The U.S. Food and Drug Administration (FDA) is warning consumers not to consume any peanuts or peanut-derived products sold by Irvington, New Jersey-based Westco Fruit and Nuts Inc. (Westco/Westcott) due to possible Salmonella contamination. Peanuts in such products may have been distributed by the Peanut Corporation of America (PCA), which recalled the peanuts because of concern about Salmonella contamination.

Antares Pharma Announces Going Concern Qualification (Business Wire via Yahoo!


Antares Pharma Announces Going Concern Qualification (Business Wire via Yahoo! Finance)
EWING, N.J.----Antares Pharma, Inc. today announced that its audited financial statements for the fiscal year ended December 31, 2008, included in the Company's Annual Report on Form 10-K, filed on March 25, 2009, contained a going concern qualification from its independent registered accounting firm, KPMG LLP.

Somaxon Receives Notice of Non-Compliance with Nasdaq Continued Listing Requirements (Business Wire via Yahoo! Finance)
SAN DIEGO----Somaxon Pharmaceuticals, Inc. , a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that on March 20, 2009 it received a letter from the Listing Qualifications Department of the Nasdaq ...

FDA Fireside Chat @ The 8th Annual MedTech Investing Conference May 6-7, 2009 (PR Newswire via Yahoo! Finance)
Billion Dollar Medical Device Market

FDA Approvals - FDA Calendar, Unbiased Reporting on Emerging Biotech Sector Now Available


FDA Calendar, Unbiased Reporting on Emerging Biotech Sector Now Available at BioMedReports.com (Business Wire via Yahoo! Finance)
PITTSBURGH----BioMedReports.com, designed by and for investors and traders, is a full news portal offering unbiased bio stock reporting and analysis about emerging biotech companies, FDA and clinical trial calendars, and valuable industry and stock market information.

Mylan seeks Tarceva and Lunesta generic approvals (AP via Yahoo! Finance)
Generic drug maker Mylan Inc. said Thursday it is seeking approval for four drugs, including low-cost versions of the sleep aid Lunesta and cancer pill Tarceva, and is being sued by the makers of each product.

FDA Approves New Indication For Wyeth's TYGACIL (tigecycline) For The Treatment Of Adult Patients With Community ... (Medical News Today)
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced that the U.S. Food and Drug Administration (FDA) approved TYGACIL(R) (tigecycline), for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by susceptible strains of indicated pathogens.

FDA Uncovers Additional Tainted Weight Loss Products The U.S. Food


FDA Uncovers Additional Tainted Weight Loss Products
The U.S. Food and Drug Administration is expanding, for the second time, its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients.

March 26-April 1, 2009 (Boulder Weekly) When Hillary Clinton, then


March 26-April 1, 2009 (Boulder Weekly)
When Hillary Clinton, then the nation s First Lady, began to champion the cause of health-care reform, her efforts were met with derision. Those opposed to change hailed the U.S. system of for-profit health care and for-profit health insurance as the best health-care system in the world.

Doctor discusses birth control options (Asheville Citizen-Times)
HENDERSONVILLE This week, Dr. Maridee Spearman of Pardee OB/GYN Associates in Hendersonville, discusses the variety of birth control options available for women.

Merck, Shering-Plough Merge in $41 Billion Big Pharma Deal (wowOwow)
Drug maker giants Merck Co. and Schering-Plough Corp. read more
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