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FDA Appoints Dr. Frank M. Torti to Senior Leadership Position


FDA Appoints Dr. Frank M. Torti to Senior Leadership Position
Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. today announced the appointment of Frank M. Torti, M.D., M.P.H. as the FDA's Principal Deputy Commissioner and first Chief Scientist.

A mom's guide to birth control (CNN.com) Question: I've always


A mom's guide to birth control (CNN.com)
Question: I've always been on the Pill, but now I'm breastfeeding. That means I can't go back on it, right?

Removal 'better than contraception' (Adelaide Now)
QUEENSLAND authorities should be removing children who have underage sex from dangerous and illegal situations, instead of implanting them with contraceptive devices, the state opposition says.

San Francisco (The San Francisco Examiner)
KENILWORTH, N.J. ( Map ) - KENILWORTH, N.J. , April 23 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today reported financial results for the first quarter of 2008, reviewed progress on its ongoing integration of Organon BioSciences N.V. (OBS) (acquired in November 2007 ) and addressed recent events affecting the Merck/Schering-Plough cholesterol franchise.

ARCHITECT CORE-M The ARCHITECT CORE-M is a lab test


ARCHITECT CORE-M
The ARCHITECT CORE-M is a lab test used to detect antibodies associated with hepatitis B (HBV) infection. ARCHITECT CORE-M Reagent Kit, Calibrators, and Controls are used to detect antibodies associated with HBV infection. (Approved: 11/6/2007)

Allergy Alert on Undeclared Dairy in 11-Ounce Single Serve Silk


Allergy Alert on Undeclared Dairy in 11-Ounce Single Serve Silk Soymilk Chocolate Flavor in Plastic Bottles (April 23)
WhiteWave Foods Company is voluntarily recalling 11-ounce plastic single serve bottles of Silk Soymilk Chocolate Flavor because it may contain undeclared milk protein.

North Aire Market Issues Allergy Alert on Possible Traces of Almonds in Chicken Dumpling Soup Mix (April 8)
North Aire Market of Shakopee, MN is recalling 99 boxes of Chicken Dumpling Soup Mix because they may contain undeclared traces of almonds. The 99 boxes were sold in various parts of the country primarily to specialty gift shops and through the company's web site under the brand, Maggie and Mary's Chicken Dumpling Soup Mix. The lot codes related to this recall are: 0730810, 0720810, 0910810, 0920811, 0920810, 0930810, 0980810, and are found on the bottom of the retail box.

Private Selection Ice Cream Recalled From Kroger Stores In Twelve Southeastern States (April 7)
Inter-American Products, Inc., a division of The Kroger Co., today announced a recall on two codes of Private Selection Light Churned Mint Chocolate Chip Ice Cream in 1.75-quart containers with a "Sell By" date of December 3, 2008. The two codes are: DEC0308 8070 and DEC0308 8080.

FDA Approvals - Akorn-Strides, LLC Announces FDA The Approvals Of Two ANDAs For


Akorn-Strides, LLC Announces FDA The Approvals Of Two ANDAs For Ondansetron Injection USP (Medical News Today)
Akorn-Strides, LLC announced the approvals of two ANDAs for Ondansetron Injection USP, 4 mg/2mL Single Dose Vials and Ondansetron Injection USP, 40 mg/20mL Multiple Dose Vials. Akorn-Strides, LLC is a Joint Venture that was formed in 2005 by Akorn, Inc. (NASDAQ: AKRX) and Strides Arcolab Limited (NSE: STAR)(BSE: 532531).

FDA Ends Probe Of Watson Pharmaceuticals Plant (Manufacturing.net)
Food and Drug Administration ended its years-long scrutiny of the drug maker's Davie, Fla., manufacturing plant, allowing products made there to be eligible for FDA approval.

Acusphere Submits New Drug Application for FDA Approval of Imagify(TM) (Centre Daily Times)
Acusphere Inc. (NASDAQ: ACUS) announced today the submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for approval to market its lead product candidate, Imagify(TM) (Perflubutane Polymer Microspheres for Injectable Suspension). Imagify is an ultrasound imaging agent for the detection of coronary artery disease, the leading cause of death in the United States. ...

FDA Approves Relistor for Opioid-Induced Constipation The U.S. Food and


FDA Approves Relistor for Opioid-Induced Constipation
The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.

Coronary Artery Plaque Imaging Device Cleared by FDA The U.S.


Coronary Artery Plaque Imaging Device Cleared by FDA
The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.

Advaxis Taps Former ''Big Pharma'' FDA Specialist (Business Wire via


Advaxis Taps Former ''Big Pharma'' FDA Specialist (Business Wire via Yahoo! Finance)
NORTH BRUNSWICK, N.J.----Advaxis Inc., , a developmental biotechnology company, has hired Christine Chansky, MD, JD, FCLM, a veteran clinician, pharmaceutical industry Medical Director, and Food & Drug Administration procedural specialist, to serve in the capacity of Executive Clinical Officer.

SPC Software controls manufacturing processes in real time. (ThomasNet)
WinSPC v7.2 offers advanced deployment and integration support as well as support for Microsoft Terminal Services implementation. It enables manufacturers to collect data from machines, devices, and data sources, monitor processes and perform SPC in real-time, and initiate corrective actions for closed-loop quality control. Also aiding with compliance of regulatory requirements, software ...

Progenics And Wyeth Announce FDA Has Approved Relistor (Medical News Today)
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced that the U.S.

FDA Approvals - Acusphere Submits New Drug Application for FDA Approval of Imagify(TM)


Acusphere Submits New Drug Application for FDA Approval of Imagify(TM) (Business Wire via Yahoo! Finance)
WATERTOWN, Mass.----Acusphere Inc. announced today the submission of a New Drug Application to the U.S. Food & Drug Administration for approval to market its lead product candidate, Imagify .

FDA Official Says Agency Cannot Ensure Safety Of All Medications Sold In U.S. (Medical News Today)
Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, on Thursday at a Senate hearing said that the number of medication ingredients manufactured abroad limits the ability of the agency to ensure the safety of all treatments sold in the U.S., CQ HealthBeat reports (Carey, CQ HealthBeat, 4/24).

FDA Approvals - Osteotech's Plexur P(TM) Receives FDA Clearance As Bone Void Filler


Osteotech's Plexur P(TM) Receives FDA Clearance As Bone Void Filler And Bone Graft Extender In Spine (Medical News Today)
Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic solutions for regenerative medicine, announced that the United States Food and Drug Administration ("FDA") has cleared its 510(k) submission for the Plexur P(TM) Biocomposite for use in spinal applications as a bone void filler and as a bone graft extender.

Akorn-Strides, LLC Announces FDA Approvals for Ondansetron Injection . USP, 4 mg/2mL Single Dose Vials and Ondansetron ... (InfoBolsa)
USP, 4 mg/2mL Single Dose Vials and Ondansetron Injection USP, 40 mg/20mL 24/04/2008 11:00:00 Business Wire US2074101013 Akorn-Strides, LLC today announced the approvals of two ANDAs for Ondansetron Injection USP, 4 mg/2mL Single Dose Vials and Ondansetron Injection USP, 40 mg/20mL Multiple Dose Vials.

FDA Approves First Compact Heart Assist Device The U.S. Food


FDA Approves First Compact Heart Assist Device
The U.S. Food and Drug Administration today approved a heart assist device with a novel design that is the first to mechanically support the weakened heart of a small-sized adult man or woman with heart failure who is at risk of dying while awaiting a heart transplant.

Federal Agents Seize Nearly $1.3 Million of Illegal Dietary Supplements


Federal Agents Seize Nearly $1.3 Million of Illegal Dietary Supplements
At the request of the U.S. Food and Drug Administration, on Wednesday U.S. Marshals seized more than $1,301,712 of dietary supplements from LG Sciences, LLC, of Brighton, Mich., because the products contain unapproved food additives and/or new dietary ingredients that cause the products to violate the law. Labeled as dietary supplements, the products are marketed for use by body builders.

Birth-Control Choices Abound for Women Over 40 (ThirdAge) ATLANTA --


Birth-Control Choices Abound for Women Over 40 (ThirdAge)
ATLANTA -- Birth-control choices are wider these days for women 40 and older -- a group that once viewed its options as pretty much limited to tube-tying surgery and condoms. For them, the pill is back. So is the IUD. Both are safer than they used to be.

'Racism to blame' for Aboriginal health problems (Australian Broadcasting Corporation)
The Australians for Native Title and Reconciliation (ANTAR) group says racism is directly to blame for many health problems in the Aboriginal community.

xTAG™ Respiratory Viral Panel (RVP) The xTAG? Respiratory Viral Panel


xTAG™ Respiratory Viral Panel (RVP)
The xTAG? Respiratory Viral Panel (RVP) assay is a new device that can simultaneously detect and identify nucleic acids of multiple respiratory viruses in nasopharyngeal swab specimens from individuals suspected of respiratory tract infections. Acute... (Approved: 1/3/2008)

KFC Issues a Nationwide Allergy Alert, Recalls Unlabeled Double Chocolate


KFC Issues a Nationwide Allergy Alert, Recalls Unlabeled Double Chocolate Chip Cakes (April 18)
KFC Corporation is voluntarily recalling its Double Chocolate Chip Cakes because they contain eggs, milk, wheat, soy ingredients and possibly traces of tree nuts, and are not individually labeled with ingredient information.

North Aire Market Issues Allergy Alert on Possible Traces of Almonds in Chicken Dumpling Soup Mix (April 8)
North Aire Market of Shakopee, MN is recalling 99 boxes of Chicken Dumpling Soup Mix because they may contain undeclared traces of almonds. The 99 boxes were sold in various parts of the country primarily to specialty gift shops and through the company's web site under the brand, Maggie and Mary's Chicken Dumpling Soup Mix. The lot codes related to this recall are: 0730810, 0720810, 0910810, 0920811, 0920810, 0930810, 0980810, and are found on the bottom of the retail box.

Grand Carnival L.L.C Issues Allergy Alert on Undeclared Milk in its "S'morestick Kit" (April 16)
The recalled "S'morestick Kits" were in limited distribution to Garden Ridge retail stores located in TX, KY, MO, TN, OK, NC, FL, SC, GA, IL, OH, VA, AR, MI, and IN, and bear the "Use By" date of "2/14/09". The "S'morestick Kit" is packaged in a clear plastic tube containing individual clear plastic packages of marshmallows, graham crackers, and chocolate pieces. S'morestick Kits subject to this recall do NOT have a "contains milk" statement following the ingredient statement affixed to the clear plastic tube. There is no health risk for consumers who are not allergic to milk.

FDA Warns Consumers about Total Body Formula and Total Body


FDA Warns Consumers about Total Body Formula and Total Body Mega Formula
The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

SYSPRO Releases New Document Management Software for Mid-Market . Manufacturers (InfoBolsa)


SYSPRO Releases New Document Management Software for Mid-Market . Manufacturers (InfoBolsa)
Manufacturers 24/04/2008 13:23:00 Business Wire US96766P1066 SYSPRO, a provider of visionary ERP for the manufacturing pragmatist, has announced the availability of Document Management for SYSPRO, a cost-effective, "green-minded" solution set that enables mid-market manufacturers to gain new cost and time efficiencies while addressing regulatory compliance mandates.

Progenics And Wyeth Announce FDA Has Approved Relistor (Medical News Today)
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced that the U.S.

FDA Approvals - Akorn-Strides, LLC Announces FDA Approvals for Ondansetron Injection USP, 4


Akorn-Strides, LLC Announces FDA Approvals for Ondansetron Injection USP, 4 mg/2mL Single Dose Vials and Ondansetron ... (Business Wire via Yahoo!7 Finance)
Akorn-Strides, LLC today announced the approvals of two ANDAs for Ondansetron Injection USP, 4 mg/2mL Single Dose Vials and Ondansetron Injection USP, 40 mg/20mL Multiple Dose Vials. Akorn-Strides, LLC is a Joint Venture that was formed in 2005 by Akorn, Inc. (NASDAQ: AKRX) and Strides Arcolab Limited (NSE: STAR)(BSE: 532531).

Relistor For Opioid-Induced Constipation Approved By The FDA (Medical News Today)
Relistor (methylnaltrexone bromide), which helps restore bowel function in patients who are in the late stages of advanced illness and receive opioids continuously for pain relief, has been approved by the Food and Drug Administration (FDA). Opioids are commonly given continuously to patients with late-stage advanced illness for pain relief.

FDA Approvals - Akorn-Strides, LLC Announces FDA Approvals for Ondansetron Injection USP, 4


Akorn-Strides, LLC Announces FDA Approvals for Ondansetron Injection USP, 4 mg/2mL Single Dose Vials and Ondansetron ... (Business Wire via Yahoo!7 Finance)
Akorn-Strides, LLC today announced the approvals of two ANDAs for Ondansetron Injection USP, 4 mg/2mL Single Dose Vials and Ondansetron Injection USP, 40 mg/20mL Multiple Dose Vials. Akorn-Strides, LLC is a Joint Venture that was formed in 2005 by Akorn, Inc. (NASDAQ: AKRX) and Strides Arcolab Limited (NSE: STAR)(BSE: 532531).

Pet Food Maker Needs Emergency Permit For Canned Foods To Enter Interstate Commerce, FDA (Medical News Today)
Evanger's Dog & Cat Food Co., Inc. has been told by the Food and Drug Administration (FDA) that it must have an emergency permit for its canned pet foods to transported and sold from state-to-state.

FDA Clears Glove Made from New Type of Latex The


FDA Clears Glove Made from New Type of Latex
The U.S. Food and Drug Administration has cleared for marketing the first device made from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the Southwestern United States.
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