August 2006 - FDA News

FDA Takes Close Look at Experience Gained from Regulations Allowing

FDA Takes Close Look at Experience Gained from Regulations Allowing Emergency Research With An Exception from Informed Consent Requirements
This federal regulation allows the conduct of research studies to test emergency treatments on patients with specific life-threatening medical conditions (head trauma, cardiac arrest, stroke) when patients cannot give informed consent because of their conditions, and family is not available to give provide consent either. Such emergency research has been allowed under very restricted circumstances since 1996 when FDA regulations went into effect providing for a narrow exception to the informed consent research requirements.

FDA Approvals - US FDA approves generic version of injectable cipro (PharmaBiz) The

US FDA approves generic version of injectable cipro (PharmaBiz)
The Food and Drug Administration (FDA) approved several Abbreviated New Drug Applications (ANDAs) for generic versions of Bayer Corporation Pharmaceutical Division's Cipro I.V., a drug to treat certain bacterial infections.

Two Florida Cancer Centers Sign On To Use Morrisville Firm s Radiation Sensor (Local Tech Wire)
MORRISVILLE, N.C. Sicel Technologies has signed on two cancer centers in Florida as the first commercial users of their implantable radiation sensor technology.

NovaDel Announces FDA Acceptance of Zensana(TM) NDA For Review (Business Wire via Yahoo! Finance)
FLEMINGTON, N.J.----Aug. 30, 2006--NovaDel Pharma today announced that the US Food and Drug Administration has accepted for review the New Drug Application for Zensana Oral Spray which was submitted by Hana Biosciences, NovaDel's North American partner for ondansetron oral spray, on June 30, 2006.

NovaDel Announces FDA Acceptance of Zensana(TM) NDA For Review (RedNova)

NovaDel Announces FDA Acceptance of Zensana(TM) NDA For Review (RedNova)
NovaDel Pharma (AMEX: NVD) today announced that

Schering-Plough to pay $435 million (AP via Yahoo! News)
Schering-Plough Corp. on Tuesday agreed to pay $435 million and plead guilty to conspiracy to settle a federal investigation into marketing of its drugs for unapproved uses and overcharging Medicaid for certain drugs.

FDA Takes Close Look at Experience Gained from Regulations Allowing

FDA Takes Close Look at Experience Gained from Regulations Allowing Emergency Research With An Exception from Informed Consent Requirements
This federal regulation allows the conduct of research studies to test emergency treatments on patients with specific life-threatening medical conditions (head trauma, cardiac arrest, stroke) when patients cannot give informed consent because of their conditions, and family is not available to give provide consent either. Such emergency research has been allowed under very restricted circumstances since 1996 when FDA regulations went into effect providing for a narrow exception to the informed consent research requirements.

Finding Ways to Make Drugs Go Down Easier: From Lollipops

Finding Ways to Make Drugs Go Down Easier: From Lollipops to Nasal Sprays, Companies Develop New Delivery Systems for (RedNova)
By Tricia Bishop, The Baltimore Sun Aug. 27--Anyone who has ever tried to give a 5-year-old an antibiotic can appreciate where Edward M. Rudnic is coming from. As the founder of Advancis Pharmaceutical Corp.

Revealed: the birth control implants given to girls of 13 (The Scotsman)
GIRLS as young as 13 have been given controversial contraceptive implants that can make them infertile for up to three years.

PhiCal? Fecal Calprotectin Immunoassay The PhiCal? Fecal Calprotectin Immnoassay is

PhiCal? Fecal Calprotectin Immunoassay
The PhiCal? Fecal Calprotectin Immnoassay is a lab test that measures the amount of fecal calprotectin in a patient?s stool sample. High levels of fecal calprotectin may be an indication of inflammatory bowel disease (IBD). Common forms of IBD include... (Approved: 4/26/2006)

Good Karma Food Technologies Issues Nationwide Allergy Alert for Good

Good Karma Food Technologies Issues Nationwide Allergy Alert for Good Karma Organic Rice Cream Mudd Pie, Mint Chocolate Chip and Chocolate Peanut Butter Fudge Products Due to Undeclared Milk Ingredient
The recall was initiated after it was revealed thru testing that the chocolate chips contained in these products contained undeclared levels of milk protein. Packages with a Best If Used By Date of July 27th, 2007 or earlier should not be consumed.

Gerber Products Company Issues Nationwide Allergy Alert on Undeclared Latex in Fashion Tint 9 Ounce Bottles (3 Packs)
The Gerber recall results from mislabeling, as the bottles in question contain latex nipples but were labeled as Gerber Fashion Tint Bottles with Silicone Nipples.

Albertsons and Chef Solutions, Inc. Recall essensia Brand Baked Potato Salad
The only product included in this recall is essensia Baked Potato Salad in a 16 oz container, bearing the use by date of AUG 17 06 WH, that may have been purchased at Albertsons stores in California, Florida, Idaho, Montana, Nevada, Oregon, Utah, or Washington.

FDA Approvals - Group Says FDA, Advisory Panels Show Bias Toward Drug Approvals

Group Says FDA, Advisory Panels Show Bias Toward Drug Approvals (Washington Post)
The panels of experts assembled by the Food and Drug Administration to advise it on whether to approve new drugs and medical devices are often biased in favor of recommending approval, according to a consumer group's analysis released yesterday.

Canadian firm buys InterVideo (Contra Costa Times)
Canadian software company Corel Corp. said Monday that it is buying Fremont-based InterVideo Inc. (IVII), a provider of multimedia DVD software, for about $196 million in cash.

CytRx Receives $24.5 Million From the ALS Charitable Remainder Trust in Exchange for a 1% Royalty Interest in Worldwide (RedNova)
CytRx Corporation (Nasdaq:CYTR): --

FDA Orders Donor Referral Services and Philip Guyett to Cease

FDA Orders Donor Referral Services and Philip Guyett to Cease Manufacturing Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) and to Retain HCT/Ps
The FDA has ordered Donor Referral Services (DRS), a human tissue-recovery firm, of Raleigh, NC, and its owner, Philip Guyett, to immediately cease all manufacturing operations, and to retain human cells, tissues, and cellular and tissue-based products (HCT/Ps) after an inspection found serious deficiencies in its manufacturing practices, including those governing donor screening and record keeping.

FDA Approvals - FDA Grants OTC Status to Barr's Plan B(R) Emergency Contraceptive

FDA Grants OTC Status to Barr's Plan B(R) Emergency Contraceptive (FinanzNachrichten)
WOODCLIFF LAKE, N.J., Aug. 24 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, ( Nachrichten ) Inc. today said that the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application (sNDA) filed by Barr's wholly-owned subsidiary, Duramed Pharmaceuticals, Inc., to market the Plan B(R) (levonorgestrel) emergency contraceptive Over-The-Counter (OTC) without a prescription.

VIVUS to Present at BioCentury's NewsMakers in the Biotech Industry Conference (RedNova)
MOUNTAIN VIEW, Calif., Aug. 28 /PRNewswire-FirstCall/ -- VIVUS, Inc. , a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products addressing obesity and sexual health, today announced that Leland F.

Complete Care Medical Initiates Aggressive Advertising Campaign (Market Wire via

Complete Care Medical Initiates Aggressive Advertising Campaign (Market Wire via Yahoo! Finance)
Complete Care Medical, Inc. finalized plans for an aggressive advertising campaign which will begin in two weeks. Complete Care Medical recently signed agreements allowing the opportunity to promote a proprietary line of newly approved FDA products in the urological arena. The advertising campaign is designed to reach consumers that utilize specific urological products.

Tissue business is easy to enter (The News & Observer)
Philip Joe Guyett, the former trader of human tissue who was ordered to shut down, says it was easy to get into the industry, and people who know the body-parts business agree.

FDA Approvals - Mylan Laboratories to Acquire Up to 71.5% Controlling Interest in

Mylan Laboratories to Acquire Up to 71.5% Controlling Interest in Matrix Laboratories (PR Newswire via Yahoo! Finance)
Mylan Laboratories Inc. and Matrix Laboratories Ltd. today announced that Mylan will acquire up to 71.5% of Matrix shares outstanding for Rs. 306 per Matrix share.

New vaccine prevents cervical cancer but also raises sexuality issues (Daily Bulletin)
Most parents willingly roll up their children's sleeves for shots to ward off everything from mumps and chickenpox to tetanus and hepatitis.

FDA expected to back expanded use of Plan B contraceptive (Boston Globe)
WASHINGTON -- The Food and Drug Administration will approve an application, possibly today, that would make the emergency contraceptive Plan B available without a prescription to women 18 and older, say sources long involved with the issue.

Consumers Advised To Avoid Raw Oysters From the Pacific Northwest

Consumers Advised To Avoid Raw Oysters From the Pacific Northwest
The Food and Drug Administration is advising consumers to avoid eating raw oysters harvested in the Pacific Northwest as a result of reports that some of the oysters recently harvested from that region were contaminated with Vibrio parahaemolyticus (Vp), a bacteria that can cause gastrointestinal illness.

Akzo Nobel Reports Strong Results Driven by Organon and Coatings;

Akzo Nobel Reports Strong Results Driven by Organon and Coatings; Revenues up 7% to EUR 3.6 Billion, Net Income Doubles (ChemPoint)
Akzo Nobel today reported substantially higher revenues and operational earnings, driven by Organon and Coatings. Operating income excluding incidentals was up 9% from EUR 334 million to EUR 365 million.

Church Outrage Over Reports that Children Have Been Given Contraceptive Implants (Catholic Times)
By The Universe's Scotland Correspondent Mairi MacDonald: The Catholic Church in Scotland has responded to newspaper reports that girls as young as 13 have been given controversial contraceptive implants that can make them infertile for up to three years.

FDA Approvals - GE Healthcare and Volcano Corporation Announce FDA Clearance of Fully-Integrated

GE Healthcare and Volcano Corporation Announce FDA Clearance of Fully-Integrated Intravascular Ultrasound Imaging on (Business Wire via Yahoo! Finance)
WAUKESHA, Wis. & RANCHO CORDOVA, Calif.----Aug. 24, 2006--GE Healthcare and Volcano Corporation today announced FDA 510 clearance for the integration of Volcano's intravascular ultrasound imaging capabilities onto the best-of-class Innova all-digital X-ray cath lab imaging system.

Plan B Approval Said Near (Washington Post)
FDA to allow sale of "morning-after" contraceptive pill without prescription to adult women, lab says.

FDA Grants OTC Status to Barr's Plan B(R) Emergency Contraceptive (FinanzNachrichten)
WOODCLIFF LAKE, N.J., Aug. 24 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, ( Nachrichten ) Inc. today said that the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application (sNDA) filed by Barr's wholly-owned subsidiary, Duramed Pharmaceuticals, Inc., to market the Plan B(R) (levonorgestrel) emergency contraceptive Over-The-Counter (OTC) without a prescription.

MonoPrep Pap Test The MonoPrep Pap Test (MPPT) system is

MonoPrep Pap Test
The MonoPrep Pap Test (MPPT) system is a device used to collect and prepare cell samples from a female patient?s cervix for Pap stain-based screening for cervical cancer, its precursor lesions and other cytologic categories and conditions. (Approved: 3/3/2006)

Sunny Lake Trading Issues Alert on Undeclared Sulfites in Dried

Sunny Lake Trading Issues Alert on Undeclared Sulfites in Dried Potato
The recalled Dried Potato, sold in six ounce, clear, uncoded plastic bags, was sold in the Brooklyn, NY area.

Fullei Fresh Recalls Alfalfa Because of Possible Health Risk
The recalled alfalfa sprouts were distributed statewide in food service establishments. The product comes in a 5-ounce, clear plastic cup container. This product was grown and packaged by Fullei Fresh, and distributed by produce companies.

Consumer Alert: Undeclared Sulfites In Dried Mushrooms
The recalled "Dried Mushrooms" are packaged in a 5-ounce, uncoded, plastic bag. They were sold nationwide. They are a product of China.

FDA Updates Consumer Advisory to Avoid Certain Raw Shellfish from

FDA Updates Consumer Advisory to Avoid Certain Raw Shellfish from the Pacific Northwest
The Food and Drug Administration is advising consumers not to eat raw clams harvested in the Pacific Northwest because of reports of a significant increase in gastrointestinal illnesses caused by Vibrio parahaemolyticus (Vp).

Utah Medical Products Chides Former FDA Attorney (RedNova) By Bob

Utah Medical Products Chides Former FDA Attorney (RedNova)
By Bob Mims, The Salt Lake Tribune Aug. 25--Robert Spiller of McLean, Va., said he was just a private citizen asking for documents offered by Utah Medical Products' Web site about its ongoing spat with the U.S. Food and Drug Administration.

FDA Approvals - FDA reportedly set to OK Plan B for over the

FDA reportedly set to OK Plan B for over the counter (Denver Post)
The Food and Drug Administration will approve an application, possibly today, that would make the long- debated emergency contraceptive Plan B available without a prescription to women 18 and older, according to sources long involved with the issue.

Plan B Approval Said Near (Washington Post)
FDA to allow sale of "morning-after" contraceptive pill without prescription to adult women, lab says.

Gen-Probe Receives FDA Clearance to Test Additional Specimen Types for STDs With the APTIMA Combo 2(R) Assay on the (FinanzNachrichten)
SAN DIEGO, Aug. 22 /PRNewswire-FirstCall/ -- Gen-Probe ( Nachrichten ) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing clearance to use the APTIMA Combo 2(R) assay to test two additional kinds of patient samples for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) on the fully automated TIGRIS(R) system.