FDA tags new GSK-Valeant med as controlled substance

GlaxoSmithKline and Valeant Pharmaceuticals can crow about the FDA approval of their new seizure drug Potiga--but how loudly? The agency did give the okay for the drug as an add-on treatment for partial onset seizures, but it also proposed making Potiga a controlled substance. Plus, it will be subject to a risk-management plan.

The drug can't be launched until the controlled-substance decision plays out. The Drug Enforcement Agency has to finish reviewing Potiga, which could take awhile. The companies expect to be able to launch it by year's end. But given the repeated delays Potiga has suffered--FDA has dragged its feet since the drug got an advisory panel's thumbs up last August--whether the companies meet that goal is anybody's guess.

Thanks to the caveats, analyst estimates for peak sales of the drug range widely, from $200 million to $800 million. Valeant itself has forecast $1.5 billion. "We believe this product will play a needed role in the management of partial onset seizures in appropriate patients who are uncontrolled on their current medications," Valeant's Susan Hall said in a statement.

The drug in March won approval in Europe, where it is marketed under the brand name Trobalt. 

- see the Reuters article
- get the story from InPharm
- read the Dow Jones news

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