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

Revlimid Reproductive Safety Concerns Led To Broad Risk Management Plan

This article was originally published in The Pink Sheet Daily

Executive Summary

Office of Drug Safety found RevAssist program acceptable for interim use of the myelodysplastic syndromes therapy until "questionable teratogenicity of lanalidomide is fully characterized and resolved."

You may also be interested in...



Celgene’s Revlimid Approved For Second-Line Multiple Myeloma

Firm will begin shipping 15 mg and 25 mg tablets at the end of the first week of July following sNDA approval announced June 29.

Celgene’s Revlimid Approved For Second-Line Multiple Myeloma

Firm will begin shipping 15 mg and 25 mg tablets at the end of the first week of July following sNDA approval announced June 29.

MGI/SuperGen’s Dacogen On Deck For Late May Launch

The myelodysplastic syndromes therapy could post $25 mil. in 2006 sales, MGI said following the May 3 approval.

Topics

UsernamePublicRestriction

Register

LL1134043

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