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

Genelabs Prestara “approvable”

Executive Summary

Genelabs plans to meet with FDA to discuss additional study for lupus treatment Prestara (prasterone) (formerly Aslera), following receipt of "approvable" letter Aug. 28. Approval is contingent upon study confirming positive effect on bone mineral density in women with mild to moderate systemic lupus erythematosus while on low-dose glucocorticoids. The product was deemed "not approvable" June 26, 2001 (1"The Pink Sheet" July 2, 2001, p. 16). Prestara will be marketed by Watson...
Advertisement

Related Content

Advertisement
UsernamePublicRestriction

Register

PS040404

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