Cephalon Gabitril REMS gets FDA approval
Cephalon said that a Risk Evaluation and Mitigation Strategy (REMS) for its antiepileptic medication Gabitril (tiagabine hydrochloride) has been approved by the US Food and Drug Administration (FDA).
Gabitril is indicated as an adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
The Gabitril REMS consists of a Medication Guide to inform patients about the potential risks associated with the use of Gabitril.
The implementation of the REMS is a result of FDA's identification in 2008 of an increased risk of suicidal thoughts and behavior with the class of antiepileptic drugs (AEDs) which includes Gabitril.
The current product labeling already contains a warning that includes this risk. The addition of a Medication Guide for patients and ongoing assessment of the REMS program is consistent with the company's commitment to safe and appropriate use of its medications.
Cephalon is a global biopharmaceutical company dedicated to discovering, developing and bringing to market medications to improve the quality of life of individuals around the world.
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