FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now
CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface.

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FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.

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FDA Clears First Automated Whole Blood Processing System in U.S. (Centre Daily Times)
Gambro BCT, Inc., soon to be known as CaridianBCT, a leading global provider of technology, products and services in automated blood collections, therapeutic systems, whole blood processes and pathogen reduction technologies, announced today that it received FDA clearance for the commercial sale of Atreus(R) Whole Blood Processing system in the United States. The Atreus system is the first ...

International Dairy Foods Association Files Lawsuit to Stop Ohio's Unfair Labeling Law (Centre Daily Times)
The International Dairy Foods Association (IDFA) today filed a lawsuit against the State of Ohio challenging its new regulations regarding the labeling of dairy products from cows that have not been treated with artificial growth hormones. In the lawsuit, IDFA says the Ohio rule interferes with the First Amendment right of its members to communicate truthful information to Ohioans and with ...

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FDA approves Akorn-Strides's two ANDAs for Famotidine Injection (Pharmaceutical Business Review)
Akorn-Strides has announced the approvals of two abbreviated new drug applications for Famotidine Injection USP, 20 mg/2mL single-dose vials and 40 mg/4mL and 200 mg/20mL multiple-dose vials.

Exciting Developments At The FDA - Annual Meeting Of The American Urological Association (Medical News Today)
ORLANDO, FL (UroToday.com) - Dr. Andrew von Eschenbach discussed developments at the FDA. He addressed the FDA mission to protect and promote public health. The FDA has been in existence since 1906. The FDA regulates 20% of everything we consume to include most food, drugs, medical devices, animal feed and drugs, cosmetics and radiation devices. The budget for this is modest at 2.

Centocor, Inc. Submits Application To FDA Requesting Approval Of Golimumab For The Treatment Of Rheumatoid Arthritis (Medical News Today)
Centocor, Inc. announced that a Biologics License Application (BLA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting the approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

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FDA Announces Limited Return of Heartworm Drug to U.S. Market
ProHeart 6 Sustained Release Injectable for Dogs, manufactured by Fort Dodge Animal Health, is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return, to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs.

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Modern birth control more than a contraceptive (The Corner News)
Birth control has been a hot button topic between parents and their children since the sexual revolution of the 1960 s, but few people realize just how long this debate has been raging.

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ELA Ovatio CRT-D System
The Ovatio CRT-D System is used to help treat congestive heart failure, a condition where the heart can not adequately pump blood around the body. It does this by providing specially timed electrical impulses to simultaneously stimulate... (Approved: 5/15/2008)

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Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27)
As a precautionary measure, Supreme Cuts LLC has announced that it is voluntarily recalling 87 cases of Off the Cob Fresh Kernel Corn in 12 oz bags. The product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people, and others with weakened immune systems.

FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.

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FDA approves Akorn-Strides's two ANDAs for Famotidine Injection (Pharmaceutical Business Review)
Akorn-Strides has announced the approvals of two abbreviated new drug applications for Famotidine Injection USP, 20 mg/2mL single-dose vials and 40 mg/4mL and 200 mg/20mL multiple-dose vials.

AspenBio Pharma Commences FDA Clinical Trial For AppyScoreTM Appendicitis Blood Test (Medical News Today)
AspenBio Pharma, Inc. (NASDAQ: APPY) an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, has officially initiated a clinical trial to support the FDA 510(k) application for the AppyScore Human Appendicitis blood-based diagnostic test.

Read more about FDA Approvals - FDA approves Akorn-Strides's two ANDAs for Famotidine Injection (Pharmaceutical Business

FDA Announces New Labeling Changes for Regranex
The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01 percent (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.

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FDA Approves Diaphragm-Pacing Device
The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator.

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73% of pharma units in Maharashtra complied revised Schedule M norms (PharmaBiz)
Almost 73 per cent of the pharmaceutical units in Maharashtra have complied with revised Schedule M norms, even as 25 per cent of the units lost their licenses for non compliance with the standards till May 2008, according to the records with the Maharashtra state Food and Drugs Administration (FDA).

Learn about the World Ophthalmic Pharmaceutical Drugs Market (Marketwire via Yahoo! Finance)
Reportlinker.com announces that a new market research report related to the Pharmaceutical industry industry is available in its catalogue.

ARX's CoSign Digital Signature Solution Provides Security, FDA Compliance and Annual Cost Savings of $150,000 for MEDRAD (PR Newswire via Yahoo! Finance)
DIA Conference -- A recent analysis by MEDRAD, a worldwide leading provider of medical devices and services that enable and enhance imaging procedures of the human body, found that the ARX's CoSign digital signature technology will produce a cost savings of $150,000 annually.

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Akorn-Strides, LLC Announces FDA Approvals for Famotidine Injection USP, 20 mg/2mL Single-Dose Vials and Famotidine ... (Business Wire via Yahoo! Finance)
BUFFALO GROVE, Ill.----Akorn-Strides, LLC today announced the approvals of two ANDAs for Famotidine Injection USP, 20 mg/2mL Single-Dose Vials and 40 mg/4mL & 200 mg/20mL Multiple-Dose Vials.

FDA Grants Priority Review For MediQuest's Drug Application To Treat Raynaud's Disease (Medical News Today)
MediQuest Therapeutics Inc. announced that it has been granted priority review status from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for MQX-503, a topical formulation designed to treat Raynaud's Disease. A priority review provides the opportunity for an approvability decision by the FDA within six months instead of the standard ten months or more.

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FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) To Full Approval For Use In Cutaneous T-Cell Lymphoma ... (Medical News Today)
Eisai Corporation of North America announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental biologics license application (sBLA) for ONTAK(R). The sBLA seeks to convert an accelerated approval indication into full approval.

FDA approves Akorn-Strides's two ANDAs for Famotidine Injection (Pharmaceutical Business Review)
Akorn-Strides has announced the approvals of two abbreviated new drug applications for Famotidine Injection USP, 20 mg/2mL single-dose vials and 40 mg/4mL and 200 mg/20mL multiple-dose vials.

Exciting Developments At The FDA - Annual Meeting Of The American Urological Association (Medical News Today)
ORLANDO, FL (UroToday.com) - Dr. Andrew von Eschenbach discussed developments at the FDA. He addressed the FDA mission to protect and promote public health. The FDA has been in existence since 1906. The FDA regulates 20% of everything we consume to include most food, drugs, medical devices, animal feed and drugs, cosmetics and radiation devices. The budget for this is modest at 2.

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FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.

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FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding
The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.

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Modern birth control more than a contraceptive (The Corner News)
Birth control has been a hot button topic between parents and their children since the sexual revolution of the 1960 s, but few people realize just how long this debate has been raging.

Read more about Modern birth control more than a contraceptive (The Corner News)

Talent™ Thoracic Stent Graft System
The Talent™ Thoracic Stent Graft System is used to repair aneurysms of the aorta in the chest. An aneurysm is a diseased, weakened and bulging section of an artery wall. The Talent™ Thoracic Stent Graft System is made of a fabric tube... (Approved: 6/5/2008)

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Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17)
Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

Lake Country Lamb Feed Voluntary Recall (June 6)
The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper.

Recall of Nestle Pure Life Purified Water (June 24)
This announces a product recall for the one-gallon Nestle Pure Life Purified Drinking Water sold ONLY in Shop-Rite stores in the five Northeast states of Connecticut, Delaware, New Jersey, New York and Pennsylvania. This affects ONLY the one-gallon size.

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FDA delays decision on expansion of Gardasil (The Star-Ledger)
Since its approval by federal regulators two years ago, the Gardasil vaccine for cervical cancer has been one of Merck's most successful new products, generating more than $1 billion in sales annually.

FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) to Full Approval for Use in Cutaneous T-Cell Lymphoma ... (PR Newswire via Yahoo! Finance)
Eisai Corporation of North America announced today that the U.S. Food and Drug Administration has accepted for priority review a supplemental biologics license application for ONTAK .

U.S. FDA Licenses Sanofi Pasteur's New Pediatric Combination Vaccine, Pentacel(R) (Medical News Today)
Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced that the U.S. Food and Drug Administration (FDA) has licensed Pentacel(R), Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine.

Read more about FDA Approvals - FDA delays decision on expansion of Gardasil (The Star-Ledger) Since