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2B or Not 2B?

Expert Sees More 505(B)(2) Filings on the 'Horizant'

By Trista Morrison


Monday, September 12, 2011
This year's FDA approval of Horizant (gabapentin enacarbil) for restless legs syndrome came with a twist: XenoPort Inc. and partner GlaxoSmithKline plc originally developed and submitted the drug for approval via the "traditional" 505(B)(1) pathway; only after receiving a complete response letter did the firms shift their strategy, refile via the 505(B)(2) pathway, and gain approval. (See BioWorld Today, Feb. 19, 2010, and April 8, 2011.)

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