Skip to Content

First Generic Version of Epilepsy Drug Sabril Approved

THURSDAY, Jan. 17, 2019 -- The first generic version of Sabril (vigabatrin) has been approved by the U.S. Food and Drug Administration to prevent complex partial seizures in adults and children 10 and older with epilepsy.

"The availability of high-quality generic alternatives of critically important medicines, once the period of patent protection or exclusivity has ended on the brand drug, helps advance access and saves consumers billions of dollars each year," said FDA Commissioner Dr. Scott Gottlieb.

A complex partial seizure originates in a certain area of the brain, typically lasting 30 seconds to 90 seconds. Disorientation, confusion, fatigue and even loss of consciousness may follow, the FDA said in a news release.

The agency repeated prior assertions that generic equivalents are held to the same vigorous manufacturing standards as brand-name drugs, and have been deemed equally safe, effective and chemically equivalent.

Vigabatrin's label includes a boxed warning of the possibility of permanent vision loss. The drug's most common side effects include dizziness, fatigue, insomnia, involuntary eye movement, blurred vision, memory impairment and weight gain. A more serious adverse reaction may be suicidal thoughts or actions, the FDA said.

Approval of generic vigabatrin tablets was granted to Teva Pharmaceuticals USA, whose parent company is based in Israel.

© 2020 HealthDay. All rights reserved.

Posted: January 2019

Read this next

Hard-to-Detect Form of Epilepsy Can Lead to Car Crashes

MONDAY, Oct. 26, 2020 -- The most common form of epilepsy is a risk factor for car crashes, yet it can have such subtle symptoms that it often goes undiagnosed for an extended...

Seizures After Vaccination Don't Affect Kids' Development: Study

WEDNESDAY, July 1, 2020 -- Kids who have a fever-related seizure after getting a vaccine won't have developmental and behavioral problems as a result, according to a new...

Aftermath of Seizures Troubling for Those With Epilepsy

FRIDAY, April 17, 2020 -- The main focus of epilepsy treatment is seizure control, but the aftereffects of seizures are also a major concern for many patients, experts say. More...