PHARMACY

Pre-emption ruling could be affected by legislation

BY Drew Buono

WASHINGTON Drugmakers waiting for the U.S. Supreme Court’s decision on preemption in Wyeth v. Levine later this year could be affected by the Medical Device Safety Act of 2008, introduced in the House to preserve state product liability lawsuits.

Saying a previous Supreme Court decision that favored preemption of state tort laws by the FDA’s authority over medical devices “ignores both congressional intent and 30 years of experience in which FDA regulation and tort liability played complementary roles in protecting consumers,” Reps. Frank Pallone, D-N.J., chairman of the House Energy and Commerce Subcommittee on Health, and Henry Waxman, D-Calif., chairman of the House Oversight and Government Reform Committee, introduced H.R. 6381.

They hope to reverse the court’s decision in Riegel v. Medtronic, in which the court ruled 8–1 that the express preemption provision of the federal Food, Drug and Cosmetic Act preempts state-law claims seeking damages for injuries caused by devices with premarket approval.

“This bill reverses [that] decision that denied victims any legal recourse and gave medical device makers blanket immunity for the life of a product,” Pallone said in a statement.

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FDA issues final approval for Perrigo’s generic Zyrtec

BY Alaric DeArment

ALLEGAN, Mich. The Food and Drug Administration has given approval to Perrigo to manufacture and market cetirizine hydrochloride syrup in 1mg per milliliter strength.

The syrup, a generic version of McNeil Consumer Healthcare’s Zyrtec syrup, relieves symptoms of allergic rhinitis.

“This approval reflects both our strategy to be first to market with important products and the unique position of the company both in front of and behind the pharmacy counter,” Perrigo Chairman and chief executive officer Joseph Papa said.

Pfizer, which originally marketed Zyrtec, reported that it had sales of $1 billion in 2007. Pfizer lost U.S. exclusivity for Zyrtec in January, according to its annual report.

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Nestea introduces green tea with higher antioxidant concentration

BY Adam Kraemer

ATLANTA Iced Tea brand Nestea announced today the launch of its new Green Tea Citrus and Diet Green Tea Citrus products with 50 percent more antioxidants than before, as well as a brand new look.

The new varieties combine all-natural fruit flavors and the natural goodness of tea, largely in response to consumer health awareness. Both products now contain 50 percent more natural tea antioxidants, with 96 milligrams of flavonoid antioxidants per eight fluid ounce serving.

“As summer approaches, it is the perfect time to introduce products for consumers who want to quickly revitalize their day,” said Penny McIntyre, senior vice president and general manager of coffee and tea for Coca-Cola North America. “Nestea offers delicious, simple blends of tea and natural fruit flavors. Our new Green Tea Citrus products with even more antioxidants are great additions to our line of refreshing teas.”

The new packaging features dynamic graphics that call attention to the antioxidant content and all-natural fruit flavors. Nestea’s Iced Tea with Lemon and Diet Iced Tea with Lemon flavors come in 20 ounce and half-liter plastic bottle 12-packs. The Iced Tea with Lemon also comes in aluminum cans (regular and diet) and 2-liter plastic bottles (regular).

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