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

Burroughs Wellcome’s Mepron (atovaquone, 566C80)

Executive Summary

Approved Nov. 25 for treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in patients who are intolerant to trimethoprim/sulfamethoxazole (TMP/SMX) therapy, FDA announces in Nov. 27 "Talk Paper." Simultaneous approval was granted by Canada's Health Protection Branch. At its Sept. 23 meeting, FDA's Antiviral Drugs Advisory Committee recommended that Mepron should be used only as a second-line therapy because of a higher mortality rate in patients who received the drug compared to TMP/SMX-treated patients ("The Pink Sheet" Sept. 28, p. 5). The NDA for Mepron was filed on April 24. Mepron has been available via Treatment IND since November 1991.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS021822

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