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VIMPAT Approval from FDA as Adjunctive Therapy in Treatment of PGTCS

The U.S. Food and Drug Administration (FDA) has approved VIMPAT® (lacosamide) CV as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients four years of age and older and VIMPAT injection for intravenous use in children four years of age and older.

VIMPAT tablets and oral solution were already approved to treat partial-onset seizures in adults and children four years and older as monotherapy and adjunctive therapy.  All three VIMPAT formulations, including injection for intravenous use, are now indicated for the treatment of partial-onset seizures and as adjunctive therapy in the treatment of PGTCS in patients four years of age and older.

This approval further emphasizes UCB’s commitment to patients and helping people living with epilepsy to gain better control of their seizures.  Like you, UCB is deeply committed to epilepsy patients and we are proud to expand that commitment through this approval.

 

VIMPAT is a prescription medicine used in people 4 years of age and older to treat partial-onset seizures and with other medicines to treat primary generalized tonic-clonic seizures. It is not known if VIMPAT is safe and effective in children under 4 years of age.

Important Safety Information
VIMPAT can cause serious side effects, including suicidal thoughts or actions; may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking; and may cause you to have an irregular heartbeat or may cause you to faint. In rare cases, cardiac arrest has been reported. VIMPAT may cause a serious allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells.

VIMPAT is a federally controlled substance (CV) because it can be abused or lead to drug dependence.

The most common side effects of VIMPAT include double vision, headache, dizziness, nausea, and sleepiness.

These are not all of the possible side effects of VIMPAT. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to UCB, Inc. at ucbCARES (1-844-599-CARE [2273]).