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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 Nexium for Use in Children Ages 1-11 Years (Feb. 28)
The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium)
for short-term use in children ages 1-11 years for the treatment of gastroesophageal
reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release
capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20
mg daily for children 1-11 years old compared to 20 mg or 40 mg recommended
for pediatric patients 12 to 17 years of age. [ Read
more ]
FDA
Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes
(Feb. 27)
The U.S. Food and Drug Administration today approved a drug to help ease
the suffering faced by those with certain chronic inflammatory diseases.
Arcalyst (rilonacept, an Interleukin-1 blocker) is now approved for the
long term treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS)
disorders: Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells
Syndrome (MWS. [ Read
more ]
FDA
Announces Permanent Injunction against Food Companies, Executives (Feb.
22)
The U.S. Food and Drug Administration today announced that Brownwood Acres
Foods Inc., Cherry Capital Services Inc. (doing business as Flavonoid
Sciences) and two of their top executives have signed a consent decree
that effectively prohibits the companies and their executives from manufacturing
and distributing any products with claims in the label or labeling to
cure, treat, mitigate or prevent diseases. [ Read
more ]
FDA
Licenses New Hemophilia Treatment (Feb. 21)
The U.S. Food and Drug Administration today licensed a treatment for hemophilia
A, a rare, hereditary blood-clotting disorder that affects approximately
15,000 individuals, almost exclusively males, in the United States. [
Read
more ]
FDA
Proposes Guidance for Dissemination of Information on Unapproved Uses
of Medical Products (Feb. 15)
The U.S. Food and Drug Administration (FDA) today issued draft guidance
on "Good Reprint Practices" for industry use in the distribution
of medical or scientific journal articles and reference publications that
involve unapproved uses of FDA-approved drugs and medical devices. [ Read
more ]
Baxter's
Multiple-dose Vial Heparin Linked to Severe Allergic Reactions (Feb. 11)
The U.S. Food and Drug Administration announced today that Baxter Healthcare
Corporation has temporarily stopped manufacturing multiple-dose vials
of the injectable blood-thinning drug heparin due to reports of serious
allergic reactions and hypotension (low blood pressure) in patients who
receive high "bolus" doses of the drug. [ Read
more ]
FDA
Notifies Public of Adverse Reactions Linked to Botox Use (Feb. 8)
The U.S. Food and Drug Administration today notified the public that Botox
and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin
Type B) have been linked in some cases to adverse reactions, including
respiratory failure and death, following treatment of a variety of conditions
using a wide range of doses. [ Read
more ]
New
Era Canning Company Expands Nationwide Recall (Feb. 7)
The U.S. Food and Drug Administration (FDA) is alerting consumers, food
service operators, and food retailers that New Era Canning Company, New
Era, Mich., is broadening its nationwide recall of canned vegetable products
for a third time because of the potential for its foods to be contaminated
with Clostridium botulinum (C. botulinum). [ Read
more ]
FDA
Clears for Market First Decellularized Heart Valve (Feb. 7)
The U.S. Food and Drug Administration today cleared for marketing the
first replacement heart valve from donated human tissue in which the cells
have been removed. [ Read
more ]
Generic
Fosamax Approved (Feb. 6)
The U.S. Food and Drug Administration today approved the first generic
versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis,
a condition that causes thinning and weakening of a person's bones. [
Read
more ]
FDA
Investigation Leads to Several Indictments for Importing Contaminated
Ingredients Used in Pet Food (Feb. 6)
The U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations
announced that two Chinese nationals and the businesses they operate,
along with a U.S. company and its president and chief executive officer,
were indicted by a federal grand jury today in separate but related cases.
The indictments are for their roles in a scheme to import products purported
to be wheat gluten into the United States that were contaminated with
melamine. These products were used to make pet food. [ Read
more ]
FDA
Takes Action to Stop the Marketing of Unapproved Injectable Drugs Containing
Colchicine (Feb. 6)
The U.S. Food and Drug Administration today announced its intention to
take enforcement action against companies marketing unapproved injectable
colchicine, a drug used to treat gout. [ Read
more ]
FDA
Advises Seafood Processors About Ciguatera Fish Poisoning in the Northern
Gulf of Mexico Near the Flower Garden Banks National Marine Sanctuary
(Feb. 5)
The U.S. Food and Drug Administration (FDA) today issued a letter to seafood
processors, advising them of recent illnesses linked to consuming fish
carrying the ciguatera toxin, which has led to cases of ciguatera fish
poisoning (CFP) in consumers. The toxic fish were harvested in the Northern
Gulf of Mexico, near the Flower Garden Banks National Marine Sanctuary,
which is located in federal waters south of the Texas-Louisiana coastline.
[ Read
more ]
President's
FY 2009 Budget Advances Food and Medical Product Safety, and the Safety
of FDA-Regulated Imports (Feb. 4)
The U.S. Food and Drug Administration, part of the U.S. Department of
Health and Human Services, is requesting nearly $2.4 billion to protect
and promote public health as part of the President's fiscal year (FY)
2009 budget—a 5.7 percent increase over the budget that the FDA received
for the current fiscal year. [ Read
more ]
FDA
Issues Public Health Advisory on Chantix (Feb. 1)
The U.S. Food and Drug Administration (FDA) today issued a Public Health
Advisory to alert health care providers, patients, and caregivers to new
safety warnings concerning Chantix (varenicline), a prescription medication
used to help patients stop smoking. [ Read
more ]
FDA
Approves Drug-Eluting Stent for Clogged Heart Arteries (Feb. 1)
The U.S. Food and Drug Administration today approved the Endeavor Zotarolimus-Eluting
Coronary Stent for use in treating patients with narrowed coronary arteries,
the blood vessels supplying the heart. [ Read
more ]
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