September 2008 - FDA News

FDA Updates Health Information Advisory on Melamine Contamination The U.S.

FDA Updates Health Information Advisory on Melamine Contamination
The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine.

Your Guide to Colorado's 2008 Ballot Measures (KJCT 8 Grand

Your Guide to Colorado's 2008 Ballot Measures (KJCT 8 Grand Junction)
Ref. O (C) Citizen-Initiated State Laws - Makes it more difficult to amend the state constitution by citizen initiative by increasing the number of required signatures to 6% of last general election for governor.

Invitrogen SPOT-Light HER2 CISH? Kit The SPOT-Light HER2 CISH

Invitrogen SPOT-Light HER2 CISH? Kit
The SPOT-Light HER2 CISH ? kit is a laboratory test that uses DNA probes to measure the number of copies of Her-2 gene on chromosome 17 in breast cancer cells by a chromogenic method. (Approved: 7/1/2008)

Allergy Alert on Undeclared Dairy in Margaritaville Island Lime Tortilla

Allergy Alert on Undeclared Dairy in Margaritaville Island Lime Tortilla Chips (September 12)
El Matador Enterprises, makers of Margaritaville Tortilla Chips is voluntarily recalling 13-ounce bags of Margaritaville Island Lime Tortilla Chips because they may contain undeclared whey in the spice blend.

Bimbo Bakeries USA Issues an Allergy Alert on Undeclared Tree Nuts in Oroweat 100 Percent Whole Wheat Bread Packaging (September 16)
Bimbo Bakeries USA today announced a voluntary recall of Oroweat 100 Percent Whole Wheat bread because it may contain tree nuts that are not listed on the label. Individuals with allergies to tree nuts run the risk of a serious and or life threatening reaction if they consume this product.

FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt

FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain
The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses.

FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal

FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections
The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.

Pro-Pharmaceuticals races to get lead product OK d (BizJournals) Pro-Pharmaceuticals Inc.

Pro-Pharmaceuticals races to get lead product OK d (BizJournals)
Pro-Pharmaceuticals Inc. is the latest struggling biotech company to face a major cash crunch, even as it comes close to submitting its lead compound to treat cancer for FDA approval.

Resurgent Health and Medical Announces That Children's Hospitals and Clinics of Minnesota has Ordered 25 CleanTech ... (PR Newswire via Yahoo! Finance)
Resurgent Health and Medical, a leader in automated handwashing and sanitizing technology, announced today that Children's Hospitals and Clinics of Minnesota has ordered 25 CleanTech IC handwashing systems for its locations in Minneapolis and St.

Survey Finds U.S. Biopharma Industry Is Moving Steadily Toward Secure Distribution (Centre Daily Times)
Pharmaceutical Commerce and Blue Vector Systems today announced survey results reporting the U.S. biopharmaceutical industry's progress in adopting serialization and addressing related supply chain challenges. Conducted online by Pharmaceutical Commerce, the Blue Vector-sponsored survey revealed that, despite the delay in California's drug pedigree legislation taking effect, the majority of ...

FDA Approvals - Elite Announces Drug Application Filing For Synthetic Narcotic Analgesic Accepted

Elite Announces Drug Application Filing For Synthetic Narcotic Analgesic Accepted by FDA (GlobeNewswire via Yahoo! Finance)
NORTHVALE, N.J., Sept. 29, 2008 -- Elite Pharmaceuticals, Inc. in collaboration with ThePharmaNetwork, LLC., announced today the acceptance by the U.S. Food and Drug Administration of the Abbreviated New Drug Application for a generic equivalent of a synthetic narcotic analgesic drug product.

FDA Grants Lilly's ALIMTA(R) (Pemetrexed for Injection) Third U.S. Approval (PR Newswire via Yahoo! Finance)
Eli Lilly and Company announced today it received approval from the U.S. Food and Drug Administration for the use of ALIMTA , in combination with cisplatin, in the first-line treatment of locally-advanced and metastatic non-small cell lung cancer , for patients with nonsquamous histology.

Cepheid Receives FDA Clearance For First Rapid On Demand Molecular Diagnostic Test For MRSA And S. Aureus (Medical News Today)
Cepheid (Nasdaq: CPHD) announced it has received clearance from the U.S.

FDA Approvals - Boston Sci climbs on FDA approval, amid warning letter (Market

Boston Sci climbs on FDA approval, amid warning letter (Market Watch)
Boston Scientific shares trade higher as the Food and Drug Administration issued new approvals for its Taxus coronary-stent system, despite an outstanding agency warning letter than generally precludes such approvals.

Boston Scientific announced that it has received FDA approval (Medical Device Link)
for the Taxus Express2 Atom drug-eluting stent system, which is the first drug-eluting stent designed for small coronary vessels. It is the first DES approved by FDA for use in vessels as small as 2.25 mm in diameter.

FDA Grants Lilly's ALIMTA(R) (Pemetrexed for Injection) Third U.S. Approval (PR Newswire via Yahoo! Finance)
Eli Lilly and Company announced today it received approval from the U.S. Food and Drug Administration for the use of ALIMTA , in combination with cisplatin, in the first-line treatment of locally-advanced and metastatic non-small cell lung cancer , for patients with nonsquamous histology.

FDA Issues Health Information Advisory on Infant Formula In response

FDA Issues Health Information Advisory on Infant Formula
In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community.

FDA Approves DNA Test to Measure Hepatitis B Virus Levels

FDA Approves DNA Test to Measure Hepatitis B Virus Levels
The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.

FDA Goes After Unapproved Eye Washes, Skin Ointments (MedicineNet.com) Title:

FDA Goes After Unapproved Eye Washes, Skin Ointments (MedicineNet.com)
Title: FDA Goes After Unapproved Eye Washes, Skin Ointments Category: Health News Created: 9/24/2008 2:00:00 AM Last Editorial Review: 9/24/2008

Anthera Completes Special Protocol Assessment With FDA and Receives EMEA Scientific Advice on Development Path Toward ... (PR Newswire via Yahoo! Finance)
Anthera Pharmaceuticals announced today they have reached agreement with the U.S. Food and Drug Administration on a Phase 3 protocol for varespladib in acute coronary syndrome under the FDA's Special Protocol Assessment procedure.

FDA Approvals - Boston Scientific Announces FDA Approval Of TAXUS(R) Express2(TM) Atom(TM) Stent

Boston Scientific Announces FDA Approval Of TAXUS(R) Express2(TM) Atom(TM) Stent System, First Drug-Eluting Stent For ... (Medical News Today)
Boston Scientific Corporation (NYSE: BSX) announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market its TAXUS(R) Express2(TM) Atom(TM) Paclitaxel-Eluting Coronary Stent System. The TAXUS Express Atom Stent is a highly deliverable drug-eluting stent (DES) specifically designed for treating small coronary vessels.

FDA extends review of Lilly blood thinner (The Indianapolis Star)
For a second time, federal regulators say they need more time to review Eli Lilly and Co.'s experimental heart drug, further delaying the launch of the Indianapolis company's most anticipated new product in years.

FDA Proposes Label Requirements for Refused Imported Foods The U.S.

FDA Proposes Label Requirements for Refused Imported Foods
The U.S. Food and Drug Administration today issued a proposed rule designed to reduce a practice known as "port shopping" which puts the safety of imported food at risk.

Implanon a convenient contraceptive (Washington State University Daily Evergreen) Implanted

Implanon a convenient contraceptive (Washington State University Daily Evergreen)
Implanted contraceptive a safe and effective option that works three ways to prevent pregnancy.

More options for birth control (Spokane Journal of Business)
Women who use nonpermanent birth control to prevent unwanted pregnancies now have a host of options from which to choose, and most don t require the daily vigilance that the traditional pill does, say women s health experts here.

Stratos LV and Stratos LV T Cardiac Resynchronization Therapy Pacemakers

Stratos LV and Stratos LV T Cardiac Resynchronization Therapy Pacemakers and Corox OTW BP and Corox OTW S BP Left Ventricular Pacing Leads
The Stratos LV (-T) Cardiac Resynchronization Therapy Pacemakers (CRT-P) are rate adaptive pulse generators that also provide Cardiac Resynchronization Therapy (CRT) for patients with heart failure. (Approved: 5/12/2008)

Bimbo Bakeries USA Issues an Allergy Alert on Undeclared Tree

Bimbo Bakeries USA Issues an Allergy Alert on Undeclared Tree Nuts in Oroweat 100 Percent Whole Wheat Bread Packaging (September 16)
Bimbo Bakeries USA today announced a voluntary recall of Oroweat 100 Percent Whole Wheat bread because it may contain tree nuts that are not listed on the label. Individuals with allergies to tree nuts run the risk of a serious and or life threatening reaction if they consume this product.

QFC Recalling Deli Tuna Salad Items in Washington and Oregon (August 28)
Quality Food Centers (QFC) said today it is recalling five deli tuna salad items sold at some QFC stores in Washington and Oregon.

FDA Approvals - Covidien Announces FDA Approval For Its Generic Myocardial Perfusion Imaging

Covidien Announces FDA Approval For Its Generic Myocardial Perfusion Imaging Kit (Medical News Today)
Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company's Abbreviated New Drug Application (ANDA) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection.

FDA Warns Companies To Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products And Topical Drug ... (Medical News Today)
The U.S. Food and Drug Administration (FDA) announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses.

FDA Approvals - Covidien Announces FDA Approval For Its Generic Myocardial Perfusion Imaging

Covidien Announces FDA Approval For Its Generic Myocardial Perfusion Imaging Kit (Medical News Today)
Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company's Abbreviated New Drug Application (ANDA) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection.

Glenmark receives US FDA approval for Betamethasone cream (PharmaBiz)
Glenmark Generics Limited's (GGL) US subsidiary has received ANDA approval from the United States Food and Drug Administration (US FDA) for Betamethasone dipropionate cream, 0.05 per cent (augmented) and will soon commence marketing and distribution of this product in the US market.

FDA Approves DNA Test to Measure Hepatitis B Virus Levels

FDA Approves DNA Test to Measure Hepatitis B Virus Levels
The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.