February 2009 - FDA News

FDA Approvals - ThermoGenesis Says FDA Concurs with Plan for Previously Announced AXP(TM)

ThermoGenesis Says FDA Concurs with Plan for Previously Announced AXP(TM) Bagset Recall (PR Newswire via Yahoo! Finance)
ThermoGenesis, Corp. , a leading supplier of innovative products and services that process and store adult stem cells, said today that the FDA has agreed with its plan to remedy the voluntary recall of certain lots of AXP disposable bagsets that it announced in November.

Daiichi, Ranbaxy form joint team to counter FDA charges (Business Standard India)
Daiichi Sankyo, which owns India s biggest drug maker, said it had formed a team with Ranbaxy Laboratories, to address the data falsification charges levied by the US Food and Drug Administration (USFDA) even as analysts foresaw more trouble for the drug maker.

FDA Approves Humanitarian Device Exemption for Deep Brain Stimulator for

FDA Approves Humanitarian Device Exemption for Deep Brain Stimulator for Severe Obsessive-Compulsive Disorder
The U.S. Food and Drug Administration today approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe obsessive-compulsive disorder (OCD).

UNFPA: More support needed to boost women reproductive health (IPP

UNFPA: More support needed to boost women reproductive health (IPP Media)
The United Nations Population Fund (UNFPA) has urged Tanzania to offer more support to women in spacing children so as to prevent them from dying while giving birth.

>Switching from Depo to Implanon - experiences? (Handbag.com)
Switching from Depo to Implanon - experiences?

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)

Glutenfreeda Foods, Inc. Recalls Peanut Envy Frozen Cookie Dough Because

Glutenfreeda Foods, Inc. Recalls Peanut Envy Frozen Cookie Dough Because of Possible Health Risk (February 24)
PEANUT ENVY was distributed throughout the United States and Canada by the following distributors: IN THE UNITED STATES: Nature's Best, CA , UNFI (Atlanta, GA, Dayville, CT, Sarasota, FL, Greenwood, IN, Iowa City, IA, Chesterfield, NH, Auburn, WA, Rocklin, CA, Ridgefield, WA, New Oxford, PA, Aurora, CO), DPT Rocky Mountain, CO, Garden Spot Dist., PA. IN CANADA: Ontario Natural Food Co-op, ON, SunOpta Grocery West, BC, SunOpta Central, ON.

Mixed Nuts Inc. Issues a Recall of Premium Orchard Rainbow Trail Mix Because it May Contain Peanuts Contaminated with Salmonella from the PCA Blakely, GA Plant (February 17)
Mixed Nuts Inc., Pacoima, CA is voluntarily recalling all of its packaged Premium Orchard Rainbow Trail Mix Trail mix sold on or prior to 1/21/09 because it may contain peanuts that have the potential to be contaminated with Salmonella.

Betty Lou's Inc. Expands Nationwide Recall Of Nut Butter Peanut Butter Protein Balls Because Of Possible Health Risk (February 26)
Betty Lou's Inc. is expanding their current recall of Betty Lou's Nut Butter Peanut Butter Protein Balls because they have the potential to be contaminated with Salmonella. The 138,156 additional balls were manufactured using peanut products recalled by Peanut Corporation of America.

FDA Issues Guidances for Industry to Improve the Safety of

FDA Issues Guidances for Industry to Improve the Safety of Food, Feed and Drugs
The U.S. Food and Drug Administration today issued three guidances designed to help ensure the safety of FDA-regulated products in the supply chain.

FDA and International Serious Adverse Events Consortium Release First Data

FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events
The first data offering health care professionals a better look into the genetic basis of certain types of adverse drug events was released today by the FDA and the International Serious Adverse Event Consortium (SAEC). The data are focused on the genetics associated with drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and helps better predict an individual's risk of developing these reactions.

FDA Takes New Regulatory Action Against Ranbaxy's Paonta Sahib Plant

FDA Takes New Regulatory Action Against Ranbaxy's Paonta Sahib Plant In India (Medical News Today)
The U.S. Food and Drug Administration announced that a facility owned by India-based Ranbaxy Laboratories falsified data and test results in approved and pending drug applications. The facility, Paonta Sahib, has been under an FDA Import Alert since September 2008.

FDA Approvals - Daiichi, Ranbaxy team to counter FDA charges (rediff.com) The USFDA

Daiichi, Ranbaxy team to counter FDA charges (rediff.com)
The USFDA has accused Ranbaxy of falsifying data and test results of medicines. A Daiichi Sankyo statement said it takes the issue very seriously. 'Both Daiichi and Ranbaxy have formed a team to solve the issue. Ranbaxy will be responding to the FDA and will continue to cooperate with the agency.' Ranbaxy shares fell more than 18 per cent to Rs 169.85 today on the Bombay Stock Exchange, while ...

FDA Says India's Largest Pharma Company Faked Test Results In Drug Applications (Medical News Today)
The US Food and Drug Administration announced on Wednesday, 25th February, that a plant belonging to India's largest pharmaceutical company, Ranbaxy Laboratories, falsified data and test results in approved and pending applications of generic drugs for the US market.

FDA Approvals - Mitral Valve Repair: Mount Sinai First In US To Implant

Mitral Valve Repair: Mount Sinai First In US To Implant FDA-Cleared Ring (Medical News Today)
David H. Adams, MD, Marie-Jos e and Henry R. Kravis Professor and Chairman of the Department of Cardiothoracic Surgery at The Mount Sinai Medical Center, performed the first two implantations of the Carpentier-Edwards Physio II ring in the United States yesterday. Dr. Adams co-invented the ring, which was cleared by the Food and Drug Administration last month, with Alain F.

Ranbaxy forged data, test results, says US drug regulator (Business Standard India)
Investigations reveal a systematic pattern of questionable data, declares FDA.

FDA Approves RiaSTAP for Treatment of Bleeding in Patients with

FDA Approves RiaSTAP for Treatment of Bleeding in Patients with Rare Genetic Defect
The U.S. Food and Drug Administration today licensed RiaSTAP, an orphan drug for the treatment of bleeding in patients with a rare genetic defect known as congenital fibrinogen deficiency. Without treatment, these patients are at risk of potentially life-threatening bleeding.

FDA Approves Orphan Drug ATryn to Treat Rare Clotting Disorder

FDA Approves Orphan Drug ATryn to Treat Rare Clotting Disorder
The U.S. Food and Drug Administration today issued its first approval for a biological product produced by genetically engineered (GE) animals.

Nephros Provides Update on 510k Applications (PR Newswire via Yahoo!

Nephros Provides Update on 510k Applications (PR Newswire via Yahoo! Finance)
Nephros, Inc. , a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, today reported that is has received initial responses from the FDA's review of the company's 510 submissions for dialysis devices.

FDA Approvals - Spectral Presents Data On The Clinical Utility Of EAA(TM) At

Spectral Presents Data On The Clinical Utility Of EAA(TM) At 13th Annual Critical Care For Endotoxemia Conference In ... (Medical News Today)
Spectral Diagnostics Inc. (TSX:SDI) announced that it presented new findings demonstrating the clinical utility of its EAA(TM) Endotoxin Activity Assay, the only FDA cleared diagnostic for the measurement of endotoxin, at the 13th Annual Critical Care for Endotoxemia congress.

Kensey Nash Announces IDE Submission For Cartilage Repair Device (Medical News Today)
Kensey Nash Corporation (Nasdaq: KNSY) announced that it has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to study the use of the Company's unique biomaterials technology for treating articular cartilage defects of the knee.

Gilead Receives Response From U.S. FDA On Company's Request For Formal Dispute Resolution For Aztreonam For Inhalation ... (Medical News Today)
Gilead Sciences, Inc. (Nasdaq:GILD) announced that the company has received a response from the U.S. Food and Drug Administration (FDA) to its appeal, submitted under the formal Dispute Resolution process, regarding the Agency's Complete Response Letter for its New Drug Application (NDA) for aztreonam for inhalation solution.

FDA Advises Public of Serious Adverse Event with Psoriasis Drug

FDA Advises Public of Serious Adverse Event with Psoriasis Drug Raptiva
The U.S. Food and Drug Administration today issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab). Three of those patients have died. All four patients were treated with the drug for more than three years. None of the patients were receiving other treatments that suppress the immune system.

>Switching from Depo to Implanon - experiences? (Handbag.com) Switching from

>Switching from Depo to Implanon - experiences? (Handbag.com)
Switching from Depo to Implanon - experiences?

Express SD Renal Monorail Premounted Stent System The Express SD

Express SD Renal Monorail Premounted Stent System
The Express SD Renal Monorail Premounted Stent System is used to re-open stenotic (narrowed) regions of the renal arteries which supply blood to the kidneys, and it consists of two components, the stent and the delivery system. (Approved: 12/11/2008)

Mixed Nuts Inc. Issues a Recall of Premium Orchard Rainbow

Mixed Nuts Inc. Issues a Recall of Premium Orchard Rainbow Trail Mix Because it May Contain Peanuts Contaminated with Salmonella from the PCA Blakely, GA Plant (February 17)
Mixed Nuts Inc., Pacoima, CA is voluntarily recalling all of its packaged Premium Orchard Rainbow Trail Mix Trail mix sold on or prior to 1/21/09 because it may contain peanuts that have the potential to be contaminated with Salmonella.

Ramsey Popcorn Co. Recalls Camp Masters Chocolatey Peanut Clusters Sold In Maryland, Mississippi And Texas Because Of Possible Risk To Health (February 19)
Ramsey Popcorn Co. is issuing a voluntary recall of 117 bags of 12 oz Chocolatey Peanut Clusters as a result of the expansion of the PCA recall related to Salmonella

FDA Approvals - ALDA Enters Into Non-Binding Letter of Intent to Purchase Pharmaceutical

ALDA Enters Into Non-Binding Letter of Intent to Purchase Pharmaceutical Manufacturing Company (CCNMatthews via Yahoo! Finance)
VANCOUVER, BRITISH COLUMBIA-- - ALDA Pharmaceuticals Corp. announces the signing of a non-binding Letter of Intent to purchase all of the business and undertakings of a pharmaceutical manufacturing firm which is operating a facility with both Health Canada and FDA approvals.

Oridion Receives FDA 510(k) Clearance For Capnostream(TM)20 Monitor With Integrated Pulmonary Index(TM) (Medical News Today)
Oridion Systems Ltd. (SIX Swiss Exchange: ORIDN). Oridion Systems Ltd. has received an FDA 510(k) clearance for its Capnostream(TM)20 Monitor with Integrated Pulmonary Index(TM).

FDA and International Serious Adverse Events Consortium Release First Data

FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events
The first data offering health care professionals a better look into the genetic basis of certain types of adverse drug events was released today by the FDA and the International Serious Adverse Event Consortium (SAEC). The data are focused on the genetics associated with drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and helps better predict an individual's risk of developing these reactions.