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FDA Grants Gralise Orphan Exclusivity But Rejects Policy Change

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA bows to a court ruling requiring it to award orphan drug market exclusivity to Depomed’s gabapentin, but the agency says it will continue to require the sponsor of a drug that is the “same” as a previously approved drug to show that it is “clinically superior” in order to be eligible.

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