Upsher-Smith Laboratories announced the recent launch of VIGADRONE® (vigabatrin) tablets, USP 500 mg. The medicine is a fully substitutable, AB-rated generic version of Sabril® (vigabatrin) tablets, 500 mg. The company also offers VIGADRONE® (vigabatrin) as an oral solution, USP 500 mg.
The medicine can be used to treat infantile spasms in patients 1 month to 2 years old, as well as refractory complex partial seizures in adults and children 2 years and older.
The U.S. FDA has approved a single shared system Risk Evaluation and Mitigation Strategy (REMS) for all vigabatrin products called the Vigabatrin REMS Program. It is required by the FDA to ensure informed risk-benefit decisions before initiating treatment and to ensure appropriate use of vigabatrin while patients are treated.