Merck & Co., Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ZEGERID OTC(TM) (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules), for over-the-counter treatment of frequent heartburn. ZEGERID OTC will be marketed over-the-counter by Schering-Plough HealthCare Products, Inc., the consumer healthcare division of Merck & Co., Inc. Schering-Plough and Merck merged on November 3, 2009.
ZEGERID OTC is a proton pump inhibitor (PPI), the strongest and most effective class of acid-reducing medications available for frequent heartburn. ZEGERID OTC treats frequent heartburn by controlling and suppressing acid for a full 24 hours, all day and all night.
ZEGERID OTC contains a patented dual-ingredient formulation that combines the leading prescription acid reducing medicine (omeprazole) with sodium bicarbonate, which protects the omeprazole from acid in the stomach. ZEGERID OTC capsules will be available in their original prescription formula, and are expected to be available at drug stores, grocery stores, mass merchandisers and club stores in the first half of 2010.
The approval provides a new and unique over-the-counter option for the estimated 50 million American adults who experience symptoms associated with frequent heartburn -- defined by symptoms occurring more than 2 times per week -- with up to 25 million Americans experiencing heartburn on a daily basis.
"ZEGERID OTC is another demonstration of our commitment to bringing innovative treatments to consumers," said Stan Barshay, executive vice president and president, Schering-Plough HealthCare Products. "For millions of Americans dealing with frequent heartburn, the availability of prescription-strength ZEGERID OTC is important news and we're pleased to offer this unique, dual-ingredient, over-the-counter product."
ZEGERID OTC(TM) is a 14-day course of treatment taken once per day to treat frequent heartburn as directed. For more information about ZEGERID OTC, visit www.ZegeridOTC.com.
ZEGERID OTC capsules add to the Schering-Plough HealthCare Products, Inc. expanding portfolio of gastrointestinal OTC products such as MiraLAX® laxative, which was launched in 2007 for the treatment of occasional constipation. ZEGERID OTC(TM) is the most recent example of the Schering-Plough HealthCare Products, Inc. legacy of successful switches of medications from prescription to over-the-counter status. This portfolio of products includes brands such as CLARITIN®, MiraLAX®, LOTRIMIN®, AFRIN®, CORICIDIN®, TINACTIN®, and DRIXORAL®. Many of these products are market-leading brands in their respective category.
Under an agreement with Santarus, a specialty pharmaceutical company that developed and currently markets prescription ZEGERID®, Schering-Plough HealthCare Products is responsible for the development, manufacturing and commercialization of ZEGERID OTC products for heartburn-related indications in the U.S. and Canada. Santarus will continue to manufacture, promote and sell its ZEGERID (omeprazole/sodium bicarbonate) products in both 20 mg and 40 mg dosage strengths in the U.S.
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