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.

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.

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.

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.

Former CEO of Seafood Importing Corporation Sentenced to Federal Prison for Importing Falsely Labeled Fish

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.

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.

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.

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.

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.

New Jersey Woman Sentenced for Committing Insurance Fraud and Selling Prescription Fertility Drugs via the Internet

At the request of the U.S. Food and Drug Administration, on Thursday, July 8, U.S. Marshals seized $230,000 worth of hand sanitizing gel made by Puerto Rico Beverage Inc. of Maunabo and distributed by Lord Pharmaceutical, LLC, doing business as Bee International Distributors. The hand sanitizer is distributed only in Puerto Rico.

The U.S. Food and Drug Administration says that as many as 79,000 illnesses and 30 deaths due to consumption of eggs contaminated with the bacterium Salmonella Enteritidis may be avoided each year with new food safety requirements for large-scale egg producers.

The U.S. Food and Drug Administration today warned that Que She, marketed as an herbal weight loss supplement, contains active pharmaceutical ingredients not listed on the product label that could harm consumers, especially those with cardiovascular conditions.

The U.S. Food and Drug Administration today warned that the unapproved use of the malaria drug Qualaquin (quinine sulfate) to treat night time leg cramps has resulted in serious side effects and prompted the manufacturer to develop a risk management plan aimed at educating health care professionals and patients about the potential risks.

The U.S. Food and Drug Administration today announced that it is inviting the public to submit comments and information to help the agency implement a new federal law that requires the posting of calorie content and other nutrition information on menu items at certain chain restaurants and similar retail food operations and vending machines.

The U.S. Food and Drug Administration today announced it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage age-related macular degeneration (AMD).

Pharmacy Owner Sentenced to Over 4 Years for Health Care Fraud, Aggravated Identity Theft and Conspiracy to Misbrand Drugs

Gulf State health and fisheries officials joined with senior leaders from several federal agencies to affirm a shared commitment to ensuring the safety of seafood coming out of the Gulf of Mexico, through closures of affected waters, surveillance, and with an eye toward reopening closed waters as soon as possible, consistent with public health goals.

On June 28, the U.S. Food and Drug Administration approved the first generic version of Effexor XR capsules (venlafaxine hydrochloride) to treat major depressive disorder.