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FDA grants marketing approval for Lundbeck's Sabril (vigabatrin)
Lundbeck, 08/24/09
H. Lundbeck A/S announced that the US Food and Drug Administration (FDA) has granted two New Drug Application (NDA) approvals for Sabril Tablets and Oral Solution. Lundbeck Inc. plans to launch Sabril in the US during the third quarter of 2009, with an extensive Risk Evaluation and Mitigation Strategy (REMS) program as required by the FDA and created in collaboration with the agency.
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