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

Orphan Medical responds to Xyrem "approvable" letter

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Orphan Medical submits Xyrem (sodium oxybate) NDA amendment Oct. 8 in response to FDA's July 2 "approvable" letter for the narcolepsy treatment. The amendment includes "revisions to product labeling and the risk management program, a safety update of ongoing clinical trials, and respiratory data collected during all night polysomnographic recordings of narcolepsy patients in a trial completed in early 2001," the firm says. The respiratory data were included to "address FDA's concern that Xyrem might have a depressant effect on respiration." The company has agreed to conduct a post-marketing trial on acute exposure in respiratory-compromised patients
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS001648

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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