Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

You may also be interested in...



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

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

Schering Claritin, Rebetol Await FDA Certification After Consent Decree

Schering-Plough's first batch of products submitted to FDA for certification under a May 16 consent decree will include the Claritin 10 mg dose and the antiviral Rebetol

Related Content

UsernamePublicRestriction

Register

LL033172

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel