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

FDA’s rating of Syntex' Synarel

Executive Summary

When Synarel (transnasal nafarelin) was approved in February for treating endometriosis, FDA gave the drug a "1B" rating denoting a new chemical entity representing a modest therapeutic gain over existing therapies ("The Pink Sheet" Feb. 19, p. 3). However, as indicated in FDA's list of February approvals, the agency changed Synarel's rating to "1 C" or a new chemical entity offering little or no therapeutic gain ("The Pink Sheet" April 16, p. 11). According to FDA, the agency decided to change the rating because it was determined that Synarel has a side effect profile similar to an already approved endometriosis treatment, Sterling's danazol (Danocrine). FDA had originally thought that Synarel's side effect profile was better than danazol's.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS017498

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