HEALTH

Exegen sues American Scientific Resources, subsidiary

BY Michael Johnsen

WATERTOWN, Mass. Exergen Corp. announced on Thursday that it has filed a lawsuit in the U.S. District Court for the District of Massachusetts against American Scientific Resources and its wholly owned subsidiary, Kidz-Med.

The lawsuit alleges false advertising with respect to claims made about the capabilities and operation of the Kidz-Med Thermofocus thermometer and requests an end to that advertising.

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CRN to host webinars with Virgo Publishing

BY Michael Johnsen

WASHINGTON The Council for Responsible Nutrition and Virgo Publishing on Wednesday announced plans to offer three webinars in 2010, with the first webinar — Dietary Supplement Safety: Understanding the Role of Adverse Event Reports in Product Recalls — taking place May 6, at 2 p.m.

The webinar will be moderated by Duffy MacKay, CRN VP scientific and regulatory affairs, and will offer attendees a better understanding around the role of a corporate post-market safety surveillance system that includes adverse event reporting to meet mandatory Food and Drug Administration reporting requirements. A panel of regulatory experts — Rick Kingston, president, SafetyCall International; Patrick Revelle, director, MedDRA MSSO; James Neal Kababick, director, Flora Research Labs; and Bob Moore of the Center For Science and Nutrition, Food and Drug Administration — will provide participants with insights on adverse event reporting, including the type and scope of information collected, how that information is reviewed and analyzed and how to both prevent and handle a product recall.

The webinars mark a continuation of a webinar partnership between CRN and Virgo that began in 2007.  The second and third webinars for 2010 will take place Aug. 3 and Nov. 4, with topics and speakers still to be determined.

“We’ve created a great combination of CRN’s knowledge of and contacts in scientific and regulatory affairs and Virgo Publishing’s expertise in producing educational webinars for the industry which is evident from our participant numbers and evaluations,” stated Judy Blatman, CRN SVP.

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Merck launches Zegerid OTC

BY Michael Johnsen

WHITEHOUSE STATION, N.J. Merck on Thursday announced that its Zegerid OTC (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) solution for frequent heartburn now is available at retail.

Zegerid OTC is the only OTC proton-pump inhibitor product with two active ingredients, combining omeprazole and sodium bicarbonate, which protects the omeprazole in this product from acid in the stomach and allows it to be absorbed.

“To date, all other OTC PPIs have used an enteric coating to prevent the medicine from being broken down by acid in the stomach prior to absorption,” explained Michael Rahmin, a gastroenterologist at The Valley Hospital in Ridgewood, N.J. and one of Castle Connolly’s 2009 Top Doctors in the New York Metro Area. “Zegerid OTC capsules do not need an enteric coating, because the sodium bicarbonate offers built-in protection against stomach acid, so the omeprazole can be absorbed by the body and get to work treating frequent heartburn.”

“With its strong history as an effective prescription product, we are excited to bring Zegerid OTC directly to consumers,” stated Bridgette Heller, president, Schering-Plough Consumer HealthCare, a division of Merck. “Our consumer healthcare division is already home to a variety of industry leading OTC products, including Claritin, Dr Scholl’s, MiraLax, Afrin and Lotrimin. We are confident that Zegerid OTC will quickly join this list of highly regarded household brands.”

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