Vigabatrin NDA Filed In The USA
Marion Merrell Dow has filed a New Drug Application with the US Food and Drug Administration for Sabril (vigabatrin), which is proposed as an add-on therapy for treating patients with complex partial seizures that have not been successfully controlled with other anticonvulsant medications. The drug is already on the market in 40 other countries.
Traditionally a lean area for new medications, epilepsy has seen an explosion in new products in recent months, with several coming to market. There has been a long-established need for new agents with equal or improved efficacy to older drugs but with fewer side effects. An estimated 30% of people with epilepsy do not have complete control of symptoms with existing drugs.
Recently, MMD and Sandoz Pharmaceuticals announced their intention to copromote the drug in the USA, a deal extending for six years from the launch of the product.
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