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FDA Approves Drug for Chronic Drooling in Children
The U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years.
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New Early Detection System Helps FDA Identify More than 100 Food Safety Problems in First 7 Months
More than 100 food safety reports were submitted by industry to the U.S. Food and Drug Administration’s new electronic portal in its first months of operation, the agency said today.
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Federal Agents Seize FastSize Extenders and FastSize EQM Erectile Quality Monitors
At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $346,954.43 worth of FastSize Extender devices and FastSize EQM Erectile Quality Monitor devices, as well as component parts used in the manufacture of the FastSize Extender. The FastSize Extender and the FastSize EQM Erectile Quality Monitor are manufactured and distributed by FastSize, LLC of Aliso Viejo, Calif.
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Pennsylvania Dairy Farm Agrees to Stop Improper Medication
Owners agree to keep illegal drug residues out of animals sold for human consumption
A Pennsylvania dairy farm has agreed to abide by federal regulations that protect meat from illegal drug residues caused by the unapproved medication of cattle before slaughter, as part of a consent decree of permanent injunction obtained by the U.S. Food and Drug Administration.
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FDA Approves First Generic Enoxaparin Sodium Injection
The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis (DVT), a potentially deadly blood clotting condition.
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Federal Government Seizes Cyanide Antidote Kits from California Company
At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $39,000 worth of products labeled as cyanide antidote kits from Keystone Pharmaceuticals in Laguna Hills, California. The seizure warrant was issued by the U.S. District Court for the Central District of California.
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FDA and Other Federal Agencies Collaborate to Improve Chemical Screening
WASHINGTON - The U.S. Environmental Protection Agency (EPA), the National Institute of Environmental Health Sciences National Toxicology Program (NTP) and the National Institute of Health Chemical Genomics Center (NCGC) welcome the U.S. Food and Drug Administration (FDA) to the Tox21 collaboration. The Tox21 collaboration merges federal agency resources (research, funding and testing tools) to develop ways to more effectively predict how chemicals will affect human health and the environment. The collaboration was established in 2008 to develop models that will be able to better predict how chemicals will affect humans. FDA will provide additional expertise and chemical safety information to improve current chemical testing methods.
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New Jersey Woman Sentenced for Committing Insurance Fraud and Selling Prescription Fertility Drugs via the Internet
New Jersey Woman Sentenced for Committing Insurance Fraud and Selling Prescription Fertility Drugs via the Internet
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FDA Warns Consumers, Pharmacists, and Wholesalers Not to Use Stolen Advair Diskus Inhalers
The FDA is warning the public that certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.
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FDA Issues Requirements for Baxter Healthcare Infusion Pump Recall
The U.S. Food and Drug Administration today required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement pump, or lease termination.
