Pink Sheet is part of the Business Intelligence Division 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 Antiviral Drugs Advisory Committee

Executive Summary

Will review Burroughs Wellcome's Metrone (NDA 20-259) on Sept. 23 for the treatment of Pneumocystic carinii pneumonia in AIDS patients who are intolerant or unresponsive to trimethoprim/sulfamethoxazole. Metrone (atovaquone), previously known as BW 566C80, has been given to approximately 800 patients under a Treatment IND. On Sept. 24, the committee will again discuss Adria's NDA (50-689) for Mycobutin (rifabutin) as a prophylactic agent for Mycobacterium avium infections in AIDS patients. A majority of the committee at its last meeting in June voted to reconsider the drug's clinical data at later meeting to give FDA time to complete its review ("The Pink Sheet" June 8, p. 3). The drug is available under a Treatment IND. The meeting begins at 8 a.m. each day at the Marriott Hotel, 620 Perry Pkwy., Gaithersburg, Md. The committee has scheduled closed deliberations for the afternoon of Sept. 24.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS021393

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