U.S. FDA panel backs Glaxo, Valeant epilepsy drug
SILVER SPRING, Maryland |
SILVER SPRING, Maryland (Reuters) - GlaxoSmithKline (GSK.L) and Valeant Pharmaceuticals Inc (VRX.N) won a U.S. advisory panel's support on Wednesday for a new drug to reduce seizures in patients with epilepsy.
The committee of Food and Drug Administration advisers voted 11-0 with two abstentions that urinary problems with the drug, Potiga, could be managed with patient monitoring.
The panel voted 13-0 that Potiga was effective for use with other epilepsy drugs for patients still having seizures. Analysts forecast peak annual sales of the drug ranging from $200 million to $800 million.
The FDA usually approves medicines that win the support of advisory panels.
Shares of Valeant and Glaxo were down amid a broad market downturn.
(Reporting by Lisa Richwine; Editing by Derek Caney)
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