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MAPLE GROVE, Minn. — Upsher-Smith Laboratories announced the launch of Vigadrone (vigabatrin) for Oral Solution, 500 mg, a fully substitutable, AA-rated generic version of Sabril (vigabatrin) powder for oral solution.
Vigadrone (vigabatrin) for Oral Solution, 500 mg.
The product was approved by the U.S. Food and Drug Administration (FDA) on June 21, 2018. The Vigabatrin powder market had U.S. sales of approximately $333 million for the 12 months ending December 31, 2017 according to IQVIA. Upsher-Smith partnered with Aucta Pharmaceuticals, LLC for product development and manufacturing.
Vigadrone is indicated for the treatment of:
- Infantile Spasms (IS)—monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.
- Refractory Complex Partial Seizures (CPS)—adjunctive therapy in patients ≥10 years of age who have responded inadequately to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss; Vigadrone is not indicated as a first line agent.
“At Upsher-Smith, we understand that physicians want to begin treating infantile spasms quickly upon diagnosis,” said Rusty Field, president and chief executive officer of Upsher-Smith. “We are supporting Vigadrone with our Access Pathways Program to help ensure that physicians will be able to start their patients on Vigadrone as quickly, and as seamlessly, as possible.”
