FDA approves J&J’s application for adult ADHD medication
RARITAN, N.J. The Food and Drug Administration has approved Johnson & Johnson’s application for Concerta for the treatment of attention deficit hyperactivity disorder in adults ages 18 to 65. The doses approved range from 18 mg to 72 mg. McNeil Pediatrics markets Concerta in the United States.
“What we’ve seen in the growing body of knowledge on adult ADHD suggests a challenging burden of impairment in everyday functioning,” said Janet Vergis, president of McNeil Pediatrics. “Recognizing this need—and as the market leader in extended-release methylphenidate for children and adolescents—we see today’s approval as a treatment option milestone for adults with ADHD and their healthcare professionals. We are proud to offer patients ages 6 to 65 with ADHD our Concerta product knowledge based on more than seven years of clinical experience.”
According to the FDA, Concerta had sales of over $1 billion in 2007.
FDA issues final approval for Perrigo’s generic Zyrtec
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.
Nestea introduces green tea with higher antioxidant concentration
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).