Upsher-Smith gets FDA nod for generic Sabril
Upsher-Smith Laboratories has received approval from the Food and Drug Administration for vigadrone, a generic version of Lundbeck’s Sabril (vigabatrin) powder for oral solution in a 500-mg dosage strength.
The product is indicated for the treatment of infantile spasms as a monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss. It also is indicated to treat refractory complex partial seizures as an adjunctive therapy in patients 10 years of age and older who have responded inadequately to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss.
Upsher-Smith partnered with Aucta Pharmaceuticals for product development and manufacturing.
Vigabatrin powder had a market value of approximately $333 million for the 12 months ending December 2017 according to IQVIA data.
The product is indicated for the treatment of infantile spasms as a monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss. It also is indicated to treat refractory complex partial seizures as an adjunctive therapy in patients 10 years of age and older who have responded inadequately to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss.
Upsher-Smith partnered with Aucta Pharmaceuticals for product development and manufacturing.
Vigabatrin powder had a market value of approximately $333 million for the 12 months ending December 2017 according to IQVIA data.