Navigation Links
Schering-Plough Announces Filing of U.S. Application for OTC ZEGERID(R)
Date:3/11/2008

KENILWORTH, N.J., March 11 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced a submission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for ZEGERID(R) (omeprazole/sodium bicarbonate) in the dosage strength of 20 mg of omeprazole as a branded over-the-counter (OTC) product to treat frequent heartburn.

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(R), 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(R) (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.

About Schering-Plough

Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. In November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company's ongoing transformation. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the future regulatory approval and potential for ZEGERID. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward- looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering- Plough's Securities and Exchange Commission filings, including Part I, Item IA. "Risk Factors" in Schering-Plough's 2007 10-K/A.


'/>"/>
SOURCE Schering-Plough Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Schering-Plough Reports Financial Results for 2007 Fourth Quarter, Full Year
2. Schering-Plough and OraSure Technologies Sign International Collaboration for Rapid Point-of-Care Oral Hepatitis C Test
3. Schering-Plough Announces Organizational Changes at Schering-Plough Research Institute
4. FDA Grants Priority Review for Schering-Ploughs Peginterferon Alfa-2b for the Adjuvant Treatment of Patients With Stage III Melanoma
5. Schering-Plough Announces Sugammadex New Drug Application Filed in Japan
6. Schering-Plough Announces New Drug Application for Sugammadex Assigned Priority Review Status by U.S. FDA
7. Schering-Plough to Webcast Presentation at Morgan Stanley Pharmaceutical CEOs Unplugged Conference
8. Schering-Plough Schedules Conference Call and Webcast for 2007 Fourth Quarter, Full-Year Financial Result
9. Schering-Plough Wins Three of Scrips Top Pharma Industry Awards
10. Schering-Plough Completes Acquisition of Organon BioSciences
11. Schering-Plough Receives Approval from European Commission for Planned Acquisition of Organon BioSciences N.V.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/20/2017)... ... February 20, 2017 , ... Researchers ... collapses in pre-term infants with respiratory distress, and assist surgeons with pre-operative ... funding through the ninth round of the University City Science Center’s QED ...
(Date:2/20/2017)... Feb. 20, 2017  Atrius Health and IBM (NYSE: ... an agreement to develop a cloud based service ... a holistic view of the multiple influences on ... Insights could be designed to support shared decision ... an innovative nonprofit healthcare organization with 875 physicians ...
(Date:2/18/2017)... ... February 17, 2017 , ... A ... in Hong Kong. , Nerium International is proud to introduce its Age-Defying Night ... Cream, NeriumAD™ Formula to consumers across Hong Kong. The luxury skincare products contain ...
(Date:2/17/2017)... 2017  If only one in every hundred ... resistance to chemotherapy, thousands of cancer cells would ... on finding these mutations in ever-smaller subpopulations of ... DNA in blood — to guide treatment decisions ... Unfortunately, however, detecting these genetic anomalies may be ...
Breaking Biology Technology:
(Date:2/8/2017)... 8, 2017 About Voice Recognition Biometrics Voice ... it against a stored voiceprint template. Acoustic features ... and tone are compared to distinguish between individual ... as most PCs already have a microphone and ... recognition biometrics are most likely to be deployed ...
(Date:2/7/2017)... 2017   MedNet Solutions , an innovative SaaS-based ... clinical research, is pleased to announce that the latest ... highly flexible and award winning eClinical solution, is now ... is a proven Software-as-a-Service (SaaS) clinical research technology ... but also delivers an entire suite of eClinical tools ...
(Date:2/3/2017)... 3, 2017 A new independent identity strategy ... LLP (IdSP) . Designed to fill a critical niche ... market, founding partners Mark Crego and ... just in identity expertise that span federal governments, the ... The Crego-Kephart combined expertise has a common theme born ...
Breaking Biology News(10 mins):