Schering-Plough Corporation Announces Completion Of cGMP Work Plan, Validation Certification Program Under FDA Consent Decree

KENILWORTH, N.J., Jan. 3 /PRNewswire-FirstCall/ -- Schering-Plough Corporation announced today that it has reported to the U.S. Food and Drug Administration that the company has completed all of the 212 significant steps and 30 validation actions required by Dec. 31, 2005, under its consent decree.

“The timely completion of our cGMP Work Plan and Validation Certification Program represents another significant milestone as we work to build the New Schering-Plough,” said Fred Hassan, Schering-Plough chairman and CEO. “Many Schering-Plough colleagues worked tirelessly and with a sustained focus to achieve this important goal. We remain committed to continuing our quality and compliance programs and look forward to the time when we can request that the consent decree be lifted.”

The obligations and requirements completed by the company under the consent decree are subject to certification by an external third party and review and approval by the U.S. Food and Drug Administration (FDA). The company cannot predict when or how long the FDA may take to complete a review of the company’s completion of its cGMP Work Plans and validation program requirements under the decree.

DISCLOSURE NOTICE: The information in this press release contains certain “forward-looking” statements, including statements relating to the timing, scope and duration of a resolution of the manufacturing issues. Forward-looking statements relate to expectations or forecasts of future events. Many factors could cause actual results to differ materially from Schering-Plough’s forward-looking statements. The forward-looking statements may be affected by the ability of Schering-Plough to assure the FDA of the quality and reliability of its manufacturing systems and controls, and the extent of remedial obligations undertaken by Schering-Plough and other uncertainties described in the company’s Securities and Exchange Commission filings under the heading “Disclosure Notice” including the company’s third quarter 2005 10-Q. The company does not assume the obligation to update any forward-looking statement.

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough’s vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.

Schering-Plough Corporation

CONTACT: Media Contact - Denise K. Foy, +1-908-298-7616; +1-908-670-0495(mobile); Investor Contact - Alex Kelly, +1-908-298-7450, both forSchering- Plough Corporation

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