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Binax Now Malaria Test The Binax Now Malaria Test is


Binax Now Malaria Test
The Binax Now Malaria Test is a rapid laboratory antigen test that can detect plasmodium parasites using a whole blood sample drawn from a vein or obtained by a finger stick. This is the first FDA product cleared for detection and identification of... (Approved: 6/13/2007)

Seoul Shik Poom, Inc. Recalls Frozen Salted Yellow Croaker and/or


Seoul Shik Poom, Inc. Recalls Frozen Salted Yellow Croaker and/or Frozen Dried Yellow Croaker Because of Possible Health Risk (Jan. 23)
Frozen Salted/Dried Yellow Croaker was distributed in New York, New Jersey and Maryland area. It reached consumers through retail stores. This product comes in a clear plastic bag and is individually tied with rope.

B. Braun's Supplier Prompts Voluntary Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flush Syringes (Jan. 18)
B. Braun Medical Inc. was recently notified by its contract manufacturer, AM2PAT Inc., of a nationwide recall of all lots and sizes of Pre-filled Heparin and Saline Flush Syringes. Customers that have the recalled product in their possession should discontinue use immediately. If patients report any problems that may be related to usage of this product a physician should be contacted.

New Era Canning Company Announces New Recall of Certain Lots of Mexican-style Chili Beans, Green Beans and Dark Red Kidney Beans Because of Possible Health Risk (Jan. 8)
New Era Canning Company of New Era, Michigan is announcing a new recall to include Mexican style chili beans, green beans, and dark red kidney beans that were shipped to food service and retail customers because a records review identified the possibility that a small number of cans from each lot may not have been adequately cooked and have the potential for the growth of Clostridium botulinum, a bacterium which can cause botulism, a potentially fatal form of food poisoning.

FDA Clears First Test Designed to Detect and Identify 12


FDA Clears First Test Designed to Detect and Identify 12 Respiratory Viruses from Single Sample
The test, called the xTAG Respiratory Viral Panel, is the first test for the detection and differentiation of influenza A subtypes H1 and H3. Influenza A is the most severe form of influenza for humans, and has been the cause of major epidemics. The new panel is also the first test for human metapneumovirus (hMPV), newly identified in 2001.

FDA Approvals - BioSante Pharmaceuticals Announces FDA Special Protocol Assessment (SPA) for LibiGel(R)


BioSante Pharmaceuticals Announces FDA Special Protocol Assessment (SPA) for LibiGel(R) in FSD (Centre Daily Times)
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that it successfully has completed and reached agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for its Phase III safety and efficacy clinical trials for LibiGel (transdermal testosterone gel) in the treatment of female sexual dysfunction (FSD), specifically, hypoactive ...

FDA warns Novartis over vaccine sterility (Reuters via Yahoo! News)
U.S. regulators warned Novartis AG that a German plant has produced contaminated vaccines, and it has failed to track down the source of the problems, a letter released on Tuesday said.

HiFi DNA Tech Questions FDA In Lawsuit - 'Why HPV DNA PCR Is Acceptable For Gardasil(R) Approval, But Not Acceptable ... (Medical News Today)
HiFi DNA Tech has filed suit against the U.S. Food and Drug Administration here in U.S. Federal District Court requesting the high court overturn the FDA's denial of HiFi's petition for reclassification of its human papillomavirus (HPV) DNA detection device from the more-restrictive class III to class II.

FDA Approves First Clotting Solution Made Using Recombinant DNA Technology


FDA Approves First Clotting Solution Made Using Recombinant DNA Technology
The U.S. Food and Drug Administration today approved the first clotting solution manufactured using recombinant DNA techniques to help stop small blood vessels from bleeding after surgery.

Milestone Scientific Names Joseph D'Agostino as Acting Chief Financial Officer


Milestone Scientific Names Joseph D'Agostino as Acting Chief Financial Officer (PR Newswire via Yahoo! Finance)
Milestone Scientific Inc. , the recognized leader in advanced injection technologies, today announced that Joseph D'Agostino, CPA, has been appointed as the Company's new Acting Chief Financial Officer, replacing former Acting CFO, Arthur Goldberg.

ARTEL Streamlines Quality Control For Automated Liquid Handlers With New MVS Feature (PharmaceuticalOnline)
ARTEL has advanced the automation of its MVS Multichannel Verification System for streamlined liquid delivery performance verification of automated liquid handlers. The MVS is a rapid, easy-to-use system that provides NIST-traceable accuracy and precision data documenting the volume dispense performance of each channel of an automated liquid handler.

FDA Approvals - Glenmark's Baddi semi-solids manufacturing facility gets US FDA nod (PharmaBiz)


Glenmark's Baddi semi-solids manufacturing facility gets US FDA nod (PharmaBiz)
Glenmark Pharmaceuticals Ltd has received US FDA approval for its state of the art semi-solids (ointments & creams) manufacturing plant at Baddi, Himachal Pradesh. This is the third Glenmark manufacturing plant to have been approved by the US FDA.

FDA Grants Medtronic Approval To Begin Clinical Trial Of First Pacemaker System Designed For Safe Use In MRI Machines (Medical News Today)
Medtronic, Inc. (NYSE: MDT) announced the start of a United States clinical trial to confirm the safety and efficacy of the Medtronic EnRhythm MRI(TM) SureScan(TM) pacing system, the first-ever pacemaker system to be developed and tested specifically for safe use in Magnetic Resonance Imaging (MRI) machines under specified scanning conditions.

Merck Receives Not Approvable Letter From FDA For OTC MEVACOR (lovastatin) 20 Mg (Medical News Today)
Merck & Co., Inc. received a not approvable letter from the U.S Food and Drug Administration (FDA) to its New Drug Application (NDA) seeking approval for over-the-counter (OTC) MEVACOR (lovastatin) 20 mg. MEVACOR OTC had been under review by the FDA since 1999; Advisory Committee reviews in 2000 and 2005 resulted in not approvable actions.

FDA Approvals - GlaxoSmithKline And Adolor Report Favourable FDA Advisory Committee Meeting For


GlaxoSmithKline And Adolor Report Favourable FDA Advisory Committee Meeting For Entereg For The Management Of ... (Medical News Today)
GlaxoSmithKline and Adolor Corporation (Nasdaq: ADLR) announced that a majority (9-6) of the Gastrointestinal Drugs Advisory Committee (GIDAC) of the U.S.

Velcura Therapeutics, Inc. Can Begin Clinical Trials Following Successful Investigational New Drug Application To U.S. ... (Medical News Today)
Velcura Therapeutics Inc., an early stage biotechnology company developing therapies for bone disease, recently completed a successful Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA). The IND enables Velcura to proceed with the first-in-man clinical trials for its lead compound, VEL-0230.

Medivation Plans To Initiate Pivotal Confirmatory Phase 3 Trial Of Dimebon(TM) For Alzheimer's Disease In Second ... (Medical News Today)
Medivation, Inc. (Nasdaq: MDVN) announced that, based on its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the Company plans to begin a pivotal confirmatory Phase 3 trial of Dimebon(TM) for mild-to-moderate Alzheimer's Disease in the second quarter of 2008.

FDA Warns Public of Contaminated Syringes The U.S. Food and


FDA Warns Public of Contaminated Syringes
The U.S. Food and Drug Administration (FDA) today announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.

FDA Approves New HIV Drug After Priority Review The U.S.


FDA Approves New HIV Drug After Priority Review
The U.S. Food and Drug Administration today approved etravirine tablets for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals.

Parents claim implant botched (Summit Sun) A Canberra couple is


Parents claim implant botched (Summit Sun)
A Canberra couple is suing a family planning clinic over an alleged botched contraceptive implant that resulted in an unwanted pregnancy.

FDA Approves Update to Label on Birth Control Patch The


FDA Approves Update to Label on Birth Control Patch
The U.S. Food and Drug Administration (FDA) today approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills.

Gene Logic to Provide EPA Access to Software and Databases


Gene Logic to Provide EPA Access to Software and Databases to Explore Strategies for Chemical Toxicity Screening (Centre Daily Times)
Gene Logic, an Ocimum Biosolutions company, announced today that it has entered into an agreement with the United States Environmental Protection Agency (EPA) National Center for Computational Toxicology (NCCT) providing access to Gene Logic's proprietary Genesis Enterprise System(R) and GX(R) Connect software and relevant portions of the ToxExpress(R) System and BioExpress(R) System. The NCCT ...

Bus-Tech, Inc. Celebrates 20th Anniversary in the Still Thriving Mainframe Storage and Disaster Recovery Market (Centre Daily Times)
Today, Bus-Tech(R), Inc., a leading supplier of data center connectivity products, announced the company's 20th Anniversary in the mainframe market. Regarded as an aging market in its final years of viability, Bus-Tech started the company in 1987. Now, twenty years later, the company is experiencing its most significant growth to date. The key to Bus-Tech's success was to continually innovate ...

Pharmaceutical, Healthcare & Life Sciences (Mondaq)
On January 16, 2008, the Food and Drug Administration (FDA) published proposed amendments to its rules governing changes to approved applications for drugs, biologics and medical devices (the Proposed Rules).

Femoral Introducer Sheath and Hemostasis Device (FISH?) The Femoral Introducer


Femoral Introducer Sheath and Hemostasis Device (FISH?)
The Femoral Introducer Sheath and Hemostasis Device (FISH?) is used to stop bleeding at a puncture site following 5, 6, or 8 French diagnostic, cardiac catheterization procedures. Instead of using manual compression (using the hands) or mechanical... (Approved: 8/20/2007)

New Era Canning Company Announces New Nationwide Recall of Green


New Era Canning Company Announces New Nationwide Recall of Green Beans and Garbanzo Beans in #10 cans (6 to 7 pound cans) (Jan. 18)
New Era Canning Company of New Era, Michigan is recalling all cans of green beans and garbanzo beans in #10 cans (large cans containing between 6 and 7 pounds) because they may have been processed under conditions which could have led to contamination by Clostridium botulinum bacterium spores, which can cause life-threatening illness or death. The codes on the affected product begin with the numbers "00249," or the letters "GREEN" or "GARB". This recall does not include Italian Green Beans because that is a different product.

AM2 PAT, Inc. Issues Nationwide Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flushes (Jan. 18)
One lot under recall of this product 1003-02, Lot 070926H, heparin IV flush syringes has been found to be contaminated with Serratia marcescens, which has resulted in patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product.

Raja Foods Issues Nationwide Recall on SWAD BRAND ABIL, GULAL, KANKU, KUM KUM, LAGAN SAMAGRI, AND POOJA SAMAGRI Containing High Levels of Lead (Jan. 16)
Raja Foods LLC of Skokie, Il is recalling its 3.5 oz. (100 g) packages of "SWAD BRAND: ABIL, GULAL, KANKU, KUM KUM," and "SWAD BRAND: LAGAN SAMAGRI KIT, and POOJA SAMAGRI KIT" because the product contains high levels of lead. Lead is very toxic and dangerous to humans, especially children, women of childbearing age, pregnant women and their unborn children.

FDA Approvals - American Society For Dermatologic Surgery Supports Current Labeling Of Allergan's


American Society For Dermatologic Surgery Supports Current Labeling Of Allergan's Botox(R) Products (Medical News Today)
The American Society for Dermatologic Surgery (ASDS), a 5,000 member specialty organization of leaders in the field of cosmetic and medically necessary skin surgery, is aware of the petition filed by Public Citizen with the U.S. Food and Drug Administration (FDA) regarding Allergan's Botox products.

Merck Receives Not Approvable Letter From FDA For OTC MEVACOR (lovastatin) 20 Mg (Medical News Today)
Merck & Co., Inc. received a not approvable letter from the U.S Food and Drug Administration (FDA) to its New Drug Application (NDA) seeking approval for over-the-counter (OTC) MEVACOR (lovastatin) 20 mg. MEVACOR OTC had been under review by the FDA since 1999; Advisory Committee reviews in 2000 and 2005 resulted in not approvable actions.

FDA Approvals - Xanthus Announces Oral Fludarabine NDA Accepted For Review By U.S.


Xanthus Announces Oral Fludarabine NDA Accepted For Review By U.S. FDA (Medical News Today)
Xanthus Pharmaceuticals, Inc., a privately-held oncology and autoimmune disease drug development company, announced that its New Drug Application (NDA) for fludarabine phosphate oral tablets (oral fludarabine) was accepted for filing by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed B-cell chronic lymphocytic leukemia (CLL).

FDA Approves Additional Indication For Astellas' MYCAMINE(R) (Medical News Today)
Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved their Supplemental New Drug Application (sNDA) seeking approval for the use of MYCAMINE(R) (micafungin sodium) for Injection in the treatment of patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses.

Recent Studies Of Vytorin, Avandia Prompt Debate About FDA Approval Process For New Medications (Medical News Today)
Recent studies that raised questions about the benefits of the cholesterol medication Vytorin, manufactured by Merck and Schering-Plough, and the safety of the type 2 diabetes treatment Avandia, manufactured by GlaxoSmithKline, are "reigniting debate" about the FDA approval process for new medications, the Wall Street Journal reports.

FDA Licenses 14 New Blood-Typing Tests On Jan. 10, the


FDA Licenses 14 New Blood-Typing Tests
On Jan. 10, the U.S. Food and Drug Administration licensed 14 new tests for determining a person's blood type, a process essential to a safe U.S. blood supply and safe transfusions.

FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs The


FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs
The U.S. Food and Drug Administration (FDA) sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency. FDA is concerned that unfounded claims like these mislead women and health care professionals.

St. Jude Medical Announces FDA Approval Of Next Generation Internet-Based


St. Jude Medical Announces FDA Approval Of Next Generation Internet-Based Data Management System For Implantable ... (Medical News Today)
St. Jude Medical, Inc. (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) approval of software and firmware updates to the Merlin.net Patient Care Network (PCN). The new Merlin.net PCN 2.5 will expand availability of the system nationwide and provide physicians with improved options for remotely monitoring their patients with the most commonly-used St.
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