Schering-Plough Announces Filing of U.S. Application for OTC ZEGERID(R)
Tuesday March 11, 8:00 am ET
KENILWORTH, N.J., March 11 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News) today announced a submission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for ZEGERID® (omeprazole/sodium bicarbonate) in the dosage strength of 20 mg of omeprazole as a branded over-the-counter (OTC) product to treat frequent heartburn.
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The NDA was submitted under the terms of a license agreement with Santarus, Inc. of San Diego, Calif., which was signed in October 2006 for the exclusive U.S./Canadian rights to market OTC ZEGERID proton pump inhibitor (PPI) products using Santarus' patented technology.
"Schering-Plough is looking forward to working with the FDA to bring this prescription product to consumers as an OTC treatment for frequent heartburn," said John E. O'Mullane, B.Sc., Ph.D., group vice president, Research and Development, Schering-Plough Consumer Health Care. "When approved, ZEGERID will be a valuable addition to our expanding portfolio of gastrointestinal OTC products such as MiraLAX®, which was launched last year for the treatment of occasional constipation."
Under the agreement with Santarus, Schering-Plough is responsible for the development, manufacturing and commercialization of ZEGERID (omeprazole/sodium bicarbonate) OTC products for heartburn-related indications in the U.S. and Canada. Santarus continues to manufacture, promote and sell its ZEGERID (omeprazole/sodium bicarbonate) prescription products in both 20 mg and 40 mg dosage strengths of omeprazole for the U.S. prescription market for PPI products.
Product Description
ZEGERID® (omeprazole/sodium bicarbonate) contains omeprazole, a proton pump inhibitor (PPI), and sodium bicarbonate, which raises the gastric pH and thus protects omeprazole from acid degradation.
Important Safety Information about ZEGERID
The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole.
ZEGERID contains sodium bicarbonate. This should be taken into consideration for patients on a sodium-restricted diet.
ZEGERID is contraindicated in patients with known hypersensitivity to any component of the formulation.
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