FDA Tagged Articles

Astellas Pharma settles whistleblower lawsuit for $7.3 million

Posted: April 17, 2014 Consumer Fraud

Astellas Pharma US Inc., which manufactures and sells pharmaceutical drugs, agreed to pay $7.3 million to the federal government to resolve claims it violated the False Claims Act. The drugmaker was charged with marketing and promoting the drug Mycamine for

FDA sued for failure to publish approval of generic testosterone drug

Posted: March 31, 2014 Pharmaceutical

Multinational generic drug manufacturer Perrigo Israel Pharmaceuticals sued the U.S. Food and Drug Administration (FDA) last Friday in a Washington D.C. federal court after the agency failed to take the appropriate measures that would allow sales of Perrigo’s generic testosterone

Lead, other toxic metals found in most lipstick samples, study finds

Posted: March 22, 2014 Personal Injury

When it comes to potentially dangerous consumer products, one of the last things that may come to mind is lipstick, yet a recent study found that many samples randomly gathered from their owners tested positive for toxic metals, including lead

FDA approves Endo’s new Aveed testosterone injections

Posted: March 11, 2014 Pharmaceutical

U.S. drug regulators gave Irish drugmaker Endo Pharmaceuticals the green light to manufacture and market its long-lasting testosterone injection Aveed in the United States, making it the latest addition to a growing list of testosterone-replacement therapies drug companies are aggressively

FDA bans the sale and distribution of four tobacco products by Jash International

Posted: February 27, 2014 Personal Injury

Utilizing its new authority under the Family Smoking Prevention and Tobacco Control Act, the U.S. Food and Drug Administration (FDA) has ordered the sale and distribution of four tobacco products on the market to end.

Medicine safety will be the topic of interest for the FDA and the EMA’s recent cluster formation

Posted: February 21, 2014 Pharmaceutical

A new ‘cluster’ on pharmacovigilance (medicine safety) topics has been established by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Used to foster communication between the EMA and regulators outside of the European Union, clusters are

Uncle Ben’s Infused Rice products recalled after students, faculty experience strange side-effects

Posted: February 11, 2014 Recalls

Students in Texas, Illinois and North Dakota experienced rashes, burning and nausea after eating Uncle Ben’s Infused Rice, leading to a recall of all Uncle Ben’s Infused Rice products by Mars Inc.

FDA reassessing testosterone drug safety

Posted: February 7, 2014 Pharmaceutical

The U.S. Food and Drug Administration (FDA) said it plans to review the safety of testosterone replacement drugs after two separate studies indicated a higher risk of adverse cardiac events in men who used the products, including one report that

FDA’s “The Real Cost” campaign will be the first of many aimed at reducing teen tobacco use

Posted: February 6, 2014 Personal Injury

In an effort to prevent youth tobacco use and reduce the number of regular teen smokers, the U.S. Food and Drug Administration (FDA) announced the launch of a new national public education campaign by the name of “The Real Cost”

Direct-to-consumer advertising likely inflating demand for testosterone drugs, new study finds

Posted: January 27, 2014 Pharmaceutical

Testosterone replacement therapy for men increased in the U.S. and the U.K. between 2000 and 2011, but whereas supplementation rates quadrupled in the U.S. during that time, they rose just 30 percent in the U.K., according to a new study