|
Recent news from the US Food and Drug Administration.
Click "read more" links to see the full article at the FDA
website. For the most up-to-date headlines, check out the FDA
Newsroom.
FDA
Approves Toviaz, a New Drug to Treat Overactive Bladder (October 31)
The U.S. Food and Drug Administration has approved a new drug to help
patients suffering from overactive bladder (OAB). Toviaz (fesoterodine
fumarate) works by relaxing the smooth muscle tissue of the bladder, thus
reducing the urinary frequency, urge to urinate, and sudden urinary incontinence
(leakage of urine), that are characteristic symptoms of OAB. [ Read
more ]
HHS/FDA
Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part
of President's Emergency Plan for AIDS Relief (October 29)
The Food and Drug Administration within the U.S. Department of Health
and Human Services (HHS) has reached the milestone of the 75th anti-retroviral
generic drug approved or tentatively approved as part of President Bush’s
Emergency Plan for AIDS Relief (PEPFAR). [ Read
more ]
FDA
Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two
Unapproved Drugs (October 28)
The U.S. Food and Drug Administration today sent Warning Letters to Bayer
HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products
— Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer
Aspirin with Heart Advantage (Bayer Heart Advantage). [ Read
more ] [ En
Español ]
FDA
Approves Lung Valve to Control Some Air Leaks after Surgery (October 24)
The U.S. Food and Drug Administration today approved an implantable and
removable valve system designed to control some air leaks in the lungs
that persist after certain kinds of lung surgery. [ Read
more ]
HHS
Preparing to Open FDA Offices in China, India, Europe, and Latin America
This Year (October 16)
Globalization of the Agency a Key Part of Import Safety Action Plan to
Enhance Product Safety. The U.S. Department of Health and Human Services
will send the first U.S. Food and Drug Administration (FDA) staff to China,
India, Europe, and Latin America before the end of 2008, HHS Secretary
Mike Leavitt announced today. [ Read
more ]
FDA
Approves Updated Labeling for Psoriasis Drug Raptiva (October 16)
Safety concerns drove labeling changes. The U.S. Food and Drug Administration
today announced labeling changes, including a Boxed Warning, to highlight
the risks of life-threatening infections, including progressive multifocal
leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling
changes are based on the FDA's post-market surveillance. The FDA is also
requiring the submission of a Risk Evaluation and Mitigation Strategy
(REMS), which will include a Medication Guide for patients and a timetable
for assessment of the REMS. [ Read
more ]
FDA
Creates Web Page with Drug Safety Information for Patients, Health Care
Professionals (October 15)
Consolidates information in one access point
Consumers and health care professionals can now go to a single page on
the U.S. Food and Drug Administration's Web site to find a wide variety
of safety information about prescription drugs. The Web page, http://www.fda.gov/cder/drugSafety.htm,
provides links to information in these categories ... [ Read
more ]
FDA
Licenses for Marketing New Therapy for Rare Genetic Disease (October 10)
The U.S. Food and Drug Administration today licensed for marketing the
first product in the United States intended to protect people with hereditary
angioedema (HAE), a rare and potentially life-threatening genetic disease.
HAE affects about 6,000 to 10,000 individuals in the United States. [
Read
more ]
FDA
Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate
Gland (October 10)
The U.S. Food and Drug Administration today approved Rapaflo (silodosin)
capsules for the treatment of symptoms due to benign prostatic hyperplasia
(BPH), a condition also known as an enlarged prostate. [ Read
more ]
FDA
Launches Food Defense Awareness Training Kit for Employees in the Food
Industry (October 10)
FIRST tool kit teaches how to reduce the risks of food contamination.
Today the U.S. Food and Drug Administration in collaboration with the
Centers for Disease Control and Prevention and the U.S. Department of
Agriculture launched its food defense awareness training kit for first
line food industry employees. The training targets these individuals because
they can play an important role in helping to keep our nation's food supply
safe, from the farm to the table. [ Read
more ]
FDA
Licenses Drug to Prevent Joint Damage in Children with Hemophilia A (October
10)
The U.S. Food and Drug Administration today approved a new use for the
blood product Kogenate FS to reduce the frequency of bleeding episodes
and prevent joint damage in children with the most severe form of hemophilia.
[ Read
more ]
FDA
Statement Following CHPA's Announcement on Nonprescription Over-the-Counter
Cough and Cold Medicines in Children (October 8)
The U.S. Food and Drug Administration supports the voluntary actions by
CHPA members to help prevent and reduce misuse and to better inform consumers
about the safe and effective use of these products for children. The FDA
continues to assess the safety and efficacy of these products and to revise
its OTC monograph (list of approved ingredients and amounts) for these
medicines. Although this new labeling is inconsistent with the current
monograph, FDA will not object, under the circumstances presented here,
to the new label modification stating "do not use in children under
4," which reflects a more restrictive use of the drugs in children.
[ Read
more ]
FDA
Approves Use of Temporary Pump to Assist Heart's Right Side (October 7)
The U.S. Food and Drug Administration today approved a Humanitarian Device
Exemption (HDE) for the first heart pump that provides certain critically
ill patients with temporary support for the right side of their heart.
[ Read
more ]
FDA
and PATH Malaria Vaccine Initiative Announce Research Collaboration (October
7)
The U.S. Food and Drug Administration has announced a collaboration with
the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests
to better predict the level of safety and effectiveness of experimental
malaria vaccines before they are used in human clinical trials. [ Read
more ]
FDA
Detects Melamine Contamination in Flavored Drink (October 6)
The U.S. Food and Drug Administration (FDA) has increased inspections
and product testing efforts in response to the melamine contamination
problem which originated in Chinese dairy products. As a result of the
FDA’s on-going testing program, the agency has detected melamine
contamination in Blue Cat Flavor Drinks. The distributor of the product,
Tristar Food Wholesale Co. Inc., initiated a recall of several flavors
of Blue Cat Flavor Drink, based on the FDA’s findings. The FDA advises
the public not to consume this product and recommends that retailers and
food service operators remove the product from sale or service. [ Read
more ]
FDA
Issues Interim Safety and Risk Assessment of Melamine and Melamine-related
Compounds in Food (October 3)
The U.S. Food and Drug Administration (FDA) today issued the results of
its interim safety and risk assessment of melamine and melamine-related
compounds in food, including infant formula. [ Read
more ]
HHS
Announces New Steps in Anthrax Preparedness (HHS release, October 1)
HHS Secretary Mike Leavitt today announced two new actions in the department’s
ongoing activities to bolster the nation’s preparedness for a potential
outdoor anthrax attack. In development since March of this year, the steps
being implemented today build upon more than a decade of preparedness
efforts across HHS and other agencies of the federal government. [ Read
more ]
|
