americanpharmaceuticalreviewFebruary 14, 2019
Tag: teva , Sabril , CPS , adjunctive therapy
Teva Pharmaceutical announced the launch of a generic version of Sabril (vigabatrin) tablets, 500 mg in the US, the first generic version of Sabril tablets to enter the US market.
Vigabatrin oral tablets are indicated as adjunctive therapy for adults and children (10 years of age or older) with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Vigabatrin tablets are not indicated as a first line treatment for CPS.
"This launch represents a notable addition to our generics portfolio and underscores our commitment to ensuring that patients with complex, chronic conditions have more treatment options," Brendan O’Grady, EVP and Head of North America Commercial at Teva said.
With over 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in seven generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
SABRIL tablets had annual sales of $180 million in the U.S., according to IQVIA data as of November 2018.
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