FDA Approves Teva's Generic Version of Epilepsy Drug
2019年1月17日 - 3:50AM
Dow Jones News
By Maria Armental
U.S. health regulators have approved the first generic version
of epilepsy drug Sabril, part of the U.S. push to lower drug
costs.
Teva Pharmaceutical Industries Ltd.'s (TEVA, TEVA.TV) generic
vigabatrin 500 mg tablets were approved by the Food and Drug
Administration to treat complex partial seizures, also called focal
seizures, given with another primary treatment in patients 10 years
old or older who have responded inadequately to alternative
treatments.
It will include a boxed warning for permanent vision loss.
The FDA had highlighted H. Lundbeck AS's (LUN.KO) Sabril, which
was first approved in the U.S. in 2009, among others without
approved generics and that had no patents or exclusivities and were
subject to distribution limitations.
Write to Maria Armental at maria.armental@wsj.com
(END) Dow Jones Newswires
January 16, 2019 13:35 ET (18:35 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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