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Larry the Cable Guy to promote new wildberry-flavored Prilosec OTC

BY Michael Johnsen

CINCINNATI — Comedian Larry the Cable Guy over the next three months will be making his way to sporting events across the country to help introduce Procter & Gamble’s recently launched Prilosec OTC Wildberry. The Cable Guy will be kicking things off at the Talladega Superspeedway Oct. 7.

Attendees will be able to celebrate wild American flavors with Larry and learn more about how to block the acid that causes frequent heartburn as he introduces new Prilosec OTC Wildberry. Larry will also encourage fans to enter the Wild American Flavor Sweepstakes. One prize pack winner will be chosen at random to receive tickets to the Super Bowl on Feb. 3, the first big auto race of the year in Daytona Beach on Feb. 24 and the basketball championship game in Atlanta on April 8.

Fans will be able to keep up with Larry’s travels by visiting WildberryFlavor.com and viewing a new video series created by Yardbarker. 


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Sanofi to visit San Francisco Walgreens on the next stop of its VacciNation Tour

BY Michael Johnsen

SWIFTWATER, Pa. — Sanofi Pasteur will bring its Fluzone Intradermal Vaccine Coop de Quill VacciNation Tour to a San Francisco Walgreens on Oct. 6 as part of its cross-country efforts to raise awareness about the seriousness of influenza and the various vaccine options that are available for adults 18 to 64 years of age this flu season.

"The one thing we know about flu season is that it’s unpredictable, and the single most important thing people can do to help prevent getting or spreading the flu is to get their annual flu vaccination," stated Melanie Malee, Walgreens market pharmacy director. "These events are an opportunity to talk with customers and others in the community about influenza and which vaccine option may be right for them. Helping protect more people from the flu is one of the ways we aim to help customers get, stay and live well."

Results from a recent national telephone survey of 663 adults revealed that low rates of vaccinations against the flu highlight a disconnect between fear and action, as 2-out-of-every-3 (67%) adults 18 through 64 years of age said if they had influenza, they fear spreading the virus to their loved ones, yet 3-in-5 (61%) adults said they are not vaccinated annually.

The survey also showed that 53% of adults 18 through 64 years of age who were vaccinated annually reported that their vaccination experience would be better if the needle was much smaller, and 65% said their experience would be better if access to the flu shot was more convenient.

A local survey of 401 adults in San Francisco revealed similar results as nearly 3-out-of-every-4 (73%) of adults 18 through 64 years of age said if they had influenza, they fear spreading the virus to their loved ones, yet more than half (55%) of adults said they are not vaccinated annually.

The Coop de Quill vehicle, which features a supersized rooftop 3-D structure of the Fluzone Intradermal vaccine, will be on-site.


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FDA issues new guidelines for budeprion XL in the 300-mg strength

BY Allison Cerra

WASHINGTON — The Food and Drug Administration has reviewed new data that indicated that budeprion XL (bupropion hydrochloride extended-release tablets) in the 300-mg strength, manufactured by Impax Labs and Teva Pharmaceuticals USA, is not therapeutically equivalent to Wellbutrin XL in the 300-mg strength.

The agency said that when it approved five generic versions of the antidepressant in the 300-mg strength, each of these generics was approved based on bioequivalence studies comparing the 150-mg strength of the products with Wellbutrin XL in the 150-mg strength. Studies, however, were not performed directly on the 300-mg strength of the products, but rather, bioequivalence studies were performed using the 150-mg strength and the results were extrapolated to establish bioequivalence of the 300-mg product, the agency said.

"[The] FDA has determined that this approach is no longer appropriate to establish bioequivalence of 300-mg bupropion hydrochloride extended-release tablets to Wellbutrin XL 300 mg, and the agency is revising its guidance to industry for how to conduct premarket bioequivalence studies in generic bupropion products," the FDA said in a statement, adding that it has changed the therapeutic equivalence rating for this product in the agency’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) to reflect this conclusion.

The move has drawn praise from the industry, particularly, the Generic Pharmaceutical Association.

"We commend the FDA for its ongoing commitment to ensuring the safety and efficacy of generic medicines," GPhA president and CEO Ralph Neas said. "Our manufacturers are dedicated to complying with FDA guidelines and providing high quality and affordable medicines to consumers and will continue their work with the agency to fulfill our joint commitment to patients. Assuring the safety and efficacy of the prescription drugs we supply is priority one. The fact that the FDA can rely on its scientific expertise to make critical decisions regarding the safety and effectiveness of pharmaceuticals &dmash; whether brand name or generic — is the surest evidence that our rigorous regulatory controls are working."


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