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Examples
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In 2009, in approving Sabril for infant seizures, the agency reviewer said the drug "does not meet the normal standards for the FDA" but that the data "suggested an effect" in lessening seizures over 24 hours.
Many 'Orphan Drugs' Get Expedited Review by FDA Thomas M. Burton 2011
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Lundbeck will pay $600 million to acquire closely held Ovation and as much as an additional $300 million within a year after closing if Ovation achieves certain milestones related to regulatory approval of Sabril.
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He said the most valuable asset in the deal is seizure and spasm drug candidate Sabril, which an expert panel recently recommended that the U.S.
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Lundbeck to launch Sabril in the US following FDA's NDA approval
THE MEDICAL NEWS Editors 2010
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Lundbeck to launch Sabril in the US following FDA's NDA approval
THE MEDICAL NEWS Editors 2010
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Lundbeck to launch Sabril in the US following FDA's NDA approval
THE MEDICAL NEWS 2010
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It may also have superior specificity to GABA aminotransferase and, possibly, a better side effects profile (e.g. less visual field defects) compared with Sabril®.
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Sabril®, to an audience of experts in the development and marketing of new and existing epilepsy therapies.
THE MEDICAL NEWS Editors 2010
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It may also have superior specificity to GABA aminotransferase and, possibly, a better side effects profile (e.g. less visual field defects) compared to Sabril®.
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The increased potency could enable the development of superior or alternative dosage forms and routes of administration compared with the marketed version of vigabatrin, Sabril® (which is marketed in the U.S. by Lundbeck Inc. for infantile spasms and refractory complex partial seizures).
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