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Merck OTC Heartburn Treatment Receives FDA Approval

San Diego-based pharmaceutical company Santarus received regulatory approval Dec. 1 for its OTC heartburn drug Zegerid. The OTC drug, licensed to Schering-Plough Health Care Products (now a unit of Merck), failed be to approved by the FDA last January.

Now, with approval, the OTC treatment could bring in $20 million for the pharmaceutical company and an additional $37.5 million in "sales milestones," Reuters reports.  Reuters is also reporting that analysts "estimate peak sales for the OTC drug to be about $100 million to $150 million."

Stan Barshay, executive vice president and president at Schering-Plough HealthCare Products, said he believes the news of the OTC drug’s approval, “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.”
 

The heartburn drug is "intended to prevent heartburn by suppressing stomach acid for 24 hours," according to The Associated Press and is expected to go to work faster combating heartburn than other OTC treatments.  

The product is expected to hit U.S. retail store shelves in the first half of 2010, according to Merck.
 

Amidst the news of the approval, Santarus stock (SNTS) jumped 36% on the NASDAQ stock exchange during trading on Dec. 2.