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:1/17/2017)... ... January 17, 2017 , ... ... Factor (RF) to its VALIDATE® SP2 calibration verification / linearity test kit. VALIDATE® ... serum base. Each VALIDATE® SP2 kit is prepared using the CLSI recommended “equal ...
(Date:1/17/2017)... N.J. , Jan. 17, 2017 Roka Bioscience, Inc. ... providing advanced testing solutions for the detection of foodborne pathogens today ... CEO.  Ms. Duseau succeeds Paul Thomas , the Company,s President ... of the Company,s Board of Directors.  The changes are effective today. ... of Directors, effective today. ...
(Date:1/17/2017)... 17, 2017 Research and Markets has ... Diagnostics - Technologies, Markets and Companies" to their offering. ... ... remarkably during the past few years. More than 1,000 companies ... and 342 of these are profiled in the report along ...
(Date:1/17/2017)... ... 17, 2017 , ... Pono Ola , a mind-body wellness firm on ... the official launch of its much-anticipated Pono Board: a re-invented fitness and anti-fatigue balance ... for over a year, the patented Pono Board is the world’s only exercise balance ...
Breaking Biology Technology:
(Date:1/4/2017)... 2017  CES 2017 – Valencell , the ... announced the launch of two new versions of ... biometric sensor modules that incorporate the best of ... expertise. The two new designs include Benchmark BE2.0, ... and Benchmark BW2.0, a 2-LED version of its ...
(Date:12/22/2016)... -- As part of its longstanding mission to improve genetic literacy ... released its latest children,s book, titled The One ... topics of inheritance and variation of traits that are part ... school classrooms in the US. The book ... Killoran , whose previous book with 23andMe, You ...
(Date:12/20/2016)... The rising popularity of mobility services ... stoking significant interest in keyless access systems. Following ... energy (BLE), biometrics and near-field communication (NFC) are ... wireless technologies in the automotive industry. This evolution ... systems opens the market to specialist companies such ...
Breaking Biology News(10 mins):