Merck & Co Receives FDA Approval For Zegerid OTC

Merck & Co has received FDA approval for Zegerid OTC (omeprazole 20mg/sodium bicarbonate 1100mg capsules), for over-the-counter treatment of frequent heartburn.

Zegerid OTC will be marketed over-the-counter by Schering-Plough HealthCare Products, the consumer healthcare division of Merck & Co Schering-Plough and Merck merged on November 3, 2009.

Zegerid OTC is a proton pump inhibitor (PPI), 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.

The company said that Zegerid OTC contains a patented dual-ingredient formulation that combines prescription acid reducing medicine (omeprazole) with sodium bicarbonate, which protects the omeprazole from acid in the stomach.

Zegerid OTC is a 14-day course of treatment taken once per day to treat frequent heartburn as directed. Reportedly, Zegerid OTC capsules will be available in their original prescription formula, and are expected to be available in the first half of 2010.

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 commercialisation of Zegerid OTC products in the US and Canada.

Santarus will continue to manufacture, promote and sell its Zegerid (omeprazole/sodium bicarbonate) products in both 20mg and 40mg dosage strengths in the US.

Stan Barshay, president and executive vice president of Schering-Plough HealthCare Products, said: “Zegerid OTC is another demonstration of our commitment to bringing innovative treatments to consumers. 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.”