FDA Leaves an Orphan Out in the Cold

In what appears to be a first, the Food and Drug Administration (FDA) recently rescinded an orphan drug exclusivity it granted two years ago to a drug company, claiming it made a mistake. In its decision, made in response to a Citizen Petition, FDA made a strong distinction between orphan drug designation, which it continued to recognize for the affected product, and orphan drug exclusivity, which it took away in this case.

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