Perrigo gets FDA approval for generic OTC Zyrtec
ALLEGAN, Mich. Perrigo earlier this week received final approval from the Food and Drug Administration to manufacture and market over-the-counter store-brand equivalents to McNeil Consumer’s Children’s Zyrtec oral solution, indicated for indoor and outdoor allergy and hives relief.
According to Wolters Kluwer data, brand sales for the original prescription strength version of the product for the last 12 months ending December 2007 were approximately $80 million.
Perrigo expects to begin shipping the product immediately.
CRN questions conclusions of vitamin study
WASHINGTON The Council for Responsible Nutrition on Wednesday countered that a recently-updated meta-analysis in the Cochrane Database of Systematic Reviews that claimed supplementation with vitamins A, E and beta-carotene could be hazardous to your long-term health does not debunk the body of scientific research that has shown that taking antioxidant supplements, including vitamins C and E, beta-carotene, zinc and selenium, consistently over the long-term, can play a role in reducing the risk of chronic disease.
“Antioxidant supplements are certainly not meant to be magic bullets and should not realistically be expected to undo a lifetime of unhealthy habits,” stated Andrew Shao, vice president, scientific and regulatory affairs, for CRN. “However, when used properly, in combination with eating a healthy diet, getting plenty of exercise, not smoking, etc., antioxidant supplements can play an important role in maintaining and promoting overall health.”
The authors of this meta-analysis examined the effects of antioxidant supplements on all-cause mortality, concluding with negative generalizations that discount most of the body of scientific research behind antioxidants supplements.
“The conclusions one can reach from this meta-analysis are very limited,” commented John Hathcock, CRN senior vice president of scientific and international affairs. “In fact, a variation of these results has already been published and was heavily criticized in its original version, due, in part, to the authors’ systematic exclusion of studies that didn’t support the hypothesis they were trying to prove. … With nearly 750 studies to choose from, it’s interesting that they chose to include only 67 studies—less than 9 percent of the total clinical trials on antioxidants that are available. “
Although the authors claimed to be assessing antioxidant supplements for the prevention of mortality, they excluded all studies—405 of them—that reported no deaths, CRN charged.
“It really comes down to whether or not this meta-analysis should mean anything to consumers or scientists,” Shao said. “And from a practical standpoint, it doesn’t mean much.”
Twinlab Fuel announces sponsorship of IBL’s Lightning
AMERICAN FORK, Utah Twinlab Fuel, a division of supplement manufacturer ISI Brands, on Wednesday announced its sponsorship of the L.A. Lightning, one of 18 professional teams in the International Basketball League.
“As an international brand, we are very excited to team up with the As the Official Sports Nutrition Supplement of the L.A. Lightning, Twinlab Fuel will provide the team with its line of sports nutrition formulas. Additionally, a Pure Fuel Energy Player of the Game will be selected at each event.
The Lightning will open the new season with a home game against the Battle Creek Knights on April 18.