Clarinex Approval Precedes Consent Decree, But Follows Schering GMP Work
Executive Summary
The approval of Schering-Plough's antihistamine Clarinex reflects the company's re-qualification and re-validation of equipment in its Las Piedras, Puerto Rico manufacturing facility
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Schering-Plough NDAs will not be subject to extra scrutiny under the GMP consent decree with FDA
Schering NDAs Are Clear For Review Under FDA Consent Decree
Schering-Plough NDAs will not be subject to extra scrutiny under the GMP consent decree with FDA
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