GSK Consumer Healthcare applauds FDA’s workshop on NRT products
PARSIPPANY, N.J. GlaxoSmithKline Consumer Healthcare on Thursday commended the Food and Drug Administration for holding a scientific workshop this week that focused on the risks and benefits associated with the long-term use of nicotine-replacement therapy products.
GSK, the manufacturer of smoking-cessation products NicoDerm and Nicorette, suggested the workshop is a first step in supporting language in the 2009 Family Smoking Prevention and Tobacco Control Act, which called upon the FDA to "consider approving the extended use of nicotine-replacement products — such as nicotine patches, nicotine gum and nicotine lozenge — for the treatment of tobacco dependence."
As a result of the FDA’s review of long-term use, GSK has submitted a statement into the FDA public docket on its position regarding the long-term use of NRT. GSK believes that using NRT products to quit smoking is far safer than continuing to smoke. NRT products offer a step-down therapy that doubles a smoker’s chances of quitting versus attempting to quit smoking “cold turkey.” Additionally, several other countries already encourage the use of NRT products for longer durations to keep people tobacco-free.
Smoking is the No. 1 preventable cause of disease and death in the United States. More than 46 million Americans smoke. Research indicated about 70% of smokers want to quit at any given time, but the success rates remain suboptimal. Tobacco use causes more than 400,000 deaths in the United States each year, and approximately 8.6 million Americans have chronic illnesses related to smoking.
Walgreens continues vitamin D giveaway program with Aetna, United Way
COLUMBIA , S.C. (May 27) One of the nation’s largest drug store chains has teamed up with a healthcare benefits company and a community solutions provider to raise awareness of the need for adequate vitamin D intake.
Walgreens, Aetna and United Way of the Midlands are continuing their efforts through a vitamin D giveaway program extension, which initially was kicked off earlier this year. The vitamin D awareness efforts will donate more than 25,000 samples, the companies said.
“We are pleased to continue our participation in this program to drive awareness around a health concern that’s seldom discussed in many communities,” said Richard Ashworth, Walgreens market VP. “Our goal is for more people to be informed that supporting a proper diet and healthy lifestyle with a vitamin D supplement is a simple step that can have long-term health benefits.”
FDA: Tri-Med selling unapproved, adulterated drugs
SILVER SPRING, Md. U.S. Marshals earlier this month seized articles of prescription and over-the-counter drug products from Tri-Med Labs in Somerset, N.J., at the request of the Food and Drug Administration, the agency announced Wednesday. The seizure warrant, issued by the U.S. District Court for the District of New Jersey and unsealed this week, shows the drugs are unapproved and adulterated new drugs.
“The FDA is taking this action because Tri-Med has refused to take these unapproved products off the market after it received warning letters and regulatory meetings,” stated Dara Corrigan, the FDA’s associate commissioner for regulatory affairs. “This action shows the FDA’s commitment to protecting the public health from the dangers of unapproved or adulterated drug products.”
The FDA has been on the case approaching 13 years — FDA inspections of Tri-Med since 1997 revealed Tri-Med continued to manufacture and distribute unapproved, misbranded and adulterated drugs with significant Good Manufacturing Practices violations.