Neuroscience
From a press release by the FDA:
Sabril Approved by FDA to Treat Spasms in Infants and Epileptic Seizures
Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children ages 1 month to 2 years. Sabril is the first drug in the United States approved to treat the disorder, characterized by a severe type of seizure that usually appears in the first year of life, typically between ages 4 months and 8 months. The disorder can be debilitating because of the frequency of difficult-to-control daily seizures.
Sabril (vigabatrin) Tablets have been approved for adult use in combination with other medications to treat complex partial seizures that have not responded adequately to previous drug therapies.
“Seizures can cause impaired nervous system function and reduced quality of life,” said Russell Katz, M.D., director of the Division of Neurology Products at the FDA’s Center for Drug Evaluation and Research. “Infantile spasms in children this young are very serious and this approval provides these patients and their parents a treatment option.”
Read the full press release
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Lundbeck's corporate press release
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Neuroscience
FDA: Lundbeck's Sabril (Vigabatrin) and Infantile Spasms
From a press release by the FDA:
Sabril Approved by FDA to Treat Spasms in Infants and Epileptic Seizures
Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children ages 1 month to 2 years. Sabril is the first drug in the United States approved to treat the disorder, characterized by a severe type of seizure that usually appears in the first year of life, typically between ages 4 months and 8 months. The disorder can be debilitating because of the frequency of difficult-to-control daily seizures.
Sabril (vigabatrin) Tablets have been approved for adult use in combination with other medications to treat complex partial seizures that have not responded adequately to previous drug therapies.
“Seizures can cause impaired nervous system function and reduced quality of life,” said Russell Katz, M.D., director of the Division of Neurology Products at the FDA’s Center for Drug Evaluation and Research. “Infantile spasms in children this young are very serious and this approval provides these patients and their parents a treatment option.”
Read the full press release
===
Lundbeck's corporate press release
- Epilepsy: Fda Approves Aptiom (eslicarbazepine Acetate) To Treat Seizures In Adults
...
- Fda: Saphris (asenapine) Approval, Schizophrenia And Bipolar
From the FDA: FDA Approves Saphris to Treat Schizophrenia and Bipolar Disorder The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to treat...
- Risperdal (risperidone) And Pediatric Schizophrenia And Bipolar Disorder
An FDA press release from yesterday: FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents The U.S. Food and Drug Administration today approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages...
- Fda Approves Invega (paliperidone)
An FDA Press Release: FOR IMMEDIATE RELEASE P06-208 December 20, 2006 Media Inquiries: Press Office, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Approves New Drug for Schizophrenia The Food and Drug Administration (FDA) today approved Invega (paliperidone)...
- Fda: Alzheimer Disease, Aricept (donepezil Hydrochloride)
From the FDA last week: FDA Approves Expanded Use of Treatment for Patients With Severe Alzheimer's Disease FOR IMMEDIATE RELEASE P06-168 October 13, 2006 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA...