Thursday, January 17, 2019 (HealthDay News)-The first generic version of Sabril (Vigabatrin) was approved by the US Food and Drug Administration to prevent complex focal epilepsy in adults with epilepsy and children over the age of 10.
“At the end of the patent protection or monopoly period for branded medicines, high-quality generic alternatives to very important medicines will be available, access will be enhanced, and consumers will save billions of dollars each year. “FDA Commissioner Dr. Scott Gottlieb said.
Complex partial epilepsy occurs in specific areas of the brain and usually lasts 30 to 90 seconds. Disorientation, confusion, malaise, and even loss of consciousness can continue, the FDA said in a news release.
Authorities reiterated previous claims that generics adhere to the same strong manufacturing standards as branded drugs and are considered equally safe, effective and chemically equivalent.
The Vigabatrin label contains a framed warning about the possibility of permanent vision loss. The most common side effects of this drug include dizziness, malaise, insomnia, involuntary eye movements, blurred vision, memory loss, and weight gain. The more serious side effects may be suicidal ideation and behavior, the FDA said.
Approval for generic bigabatrin tablets has been granted to Teva Pharmaceuticals USA, whose parent company is based in Israel.
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The first generic version of the epilepsy drug Sabril has been approved
Source link The first generic version of the epilepsy drug Sabril has been approved
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