Archive: January, 2013
The millions of Americans who use sleep drugs were warned last week by the U.S. Food and Drug Administration to talk to their doctor about lowering the dosage of a commonly used type of insomnia drug in hopes that less of the drug will be in the bloodstream the next morning when the person gets behind the wheel to drive somewhere.
IMS Health, a health care technology and information company with an office in Plymouth Meeting, said about 60 million prescriptions were written for all sleeping pills in 2011, with about two thirds of those being some form of zolpidem. The drug is sold as a generic and under the brand names Ambien, Ambien CR, Edluar and Zolpimist.
“Over the years FDA has received spontaneous adverse event reports of driving impairment and motor vehicle accidents associated with zolpidem, but these reports lacked the information necessary to fully understand whether and how zolpidem affected people’s mental alertness and ability to drive,” Dr. Ellis Unger, a director in the FDA's Center for Drug Evaluation and Research said in a statement. “Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment.”
Trying to reduce the 15,000-plus annual deaths from inappropriate use of prescription opioid painkillers, the U.S. Food and Drug Administration Wednesday issued draft guidance to assist and encourage pharmaceutical companies in developing new forms of the drugs with abuse-deterrent properties.
Some addicts swallow too many pills. Others break or crush the pills, some snort and some liquefy the drug for injection.
Driving is dangerous enough without falling asleep at the wheel, so the U.S. Food and Drug Administration Thursday urged patients and doctors to lower the bedtime doses of a common insomnia drug, which was prescribed about 40 million times in 2011.
The new safety warnings are for the sleep drug zolpidem, which is sold as a generic and under the brand names Ambien, Ambien CR, Edluar and Zolpimist.
The new warnings came after clinical tests for a recently-approved drug were coupled with tests involving driving simulators. The FDA will now require driving simulation tests be done as part of any new application for insomnia drugs.
Jeremy Levin was hired as chief executive officer of Teva Pharmaceuticals on Jan. 1, 2012 to help revive the languishing stock price and he has been trying to rally Wall Street for a bit more than a year.
He tried again Tuesday during his presentation at the J.P. Morgan Chase Healthcare Conference in San Francisco.
"This is a company with tremendous capability," said Levin, who took control on May 9.
Sanofi said Monday it bought Rolaids antacid brand products from the McNeil Consumer Healthcare Unit of Johnson & Johnson.
The company did not reveal a price in its Monday morning announcement.
McNeil Consumer Healthcare is based in Fort Washington, Montgomery County, and is under the umbrella of McNeil, PPC, which is part of J&J's consumer branch.
Endo Health Solutions, which will soon move its headquarters from Chadds Ford to Malvern, said Thursday night that it will more than triple the money it has set aside to cover possible penalties stemming from a federal investigation into how the company promoted and sold its Lidoderm patch painkilling drug.
Endo set aside about $53 million in the third quarter of 2012, but said Thursday that it would bump that figure to approximately $194 million.
The announcement came after the market closed Thursday. Endo's closing price was $26.25, down 12 cents on the day and near its 52-week low of $25.49.
The FDA's announcement of approval of Sirturo to treat multi-drug resistant tuberculosis was certainly a high note for Janssen, the Johnson & Johnson subsidiary which makes the drug in Titusville, N.J.
"Sirturo was first discovered in our laboratories more than a decade ago and it is gratifying to see our discovery and development lead to the accelerated approval of the first TB therapy in 40 years with a new mechanism of action. This underscores our commitment as a company to discover, develop and responsibly deliver innovative medicines that address serious unmet medical needs," Dr. Paul Stoffels, chief scientific officer of pharmaceuticals at Johnson & Johnson, said in a statement.
Tuesday's Inquirer story is here.