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

Vigabatrin slated for advisory committee

Executive Summary

Ovation's Sabril (vigabatrin) is going before FDA's Peripheral and Central Nervous System Drugs Advisory Committee for two epilepsy indications. GABA-transaminase inhibitor, which has a long 34-year history, will be reviewed Aug. 6-7 in Silver Spring, Md. Ovation is seeking approval for two indications, as adjunctive therapy for the treatment of refractory complex partial seizures in adults and treatment of infantile spasms. The firm said FDA had accepted the two NDAs for Sabril and granted priority review for the infantile indication in February. Ovation says now that it expects final approval by the end of the fourth quarter. The delay is nominal given that vigabatrin was originally deemed "approvable" by FDA in 1997 for adult seizures; the product was then owned by Aventis (now Sanofi-Aventis). One safety issue likely to be raised by the panel is a peripheral visual field defect
Advertisement

Related Content

Advertisement
UsernamePublicRestriction

Register

PS049872

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