FDA rejects orphan exclusivity for Eagle Pharma's bendamustine

Shares of Eagle Pharmaceuticals ($EGRX) slid about 8% this morning after the Woodcliff Lake, NJ-based biotech announced that the FDA had spurned its request for 7 years of orphan drug exclusivity in the U.S., for BENDEKA (bendamustine hydrochloride injection, or bendamustine HCI). Eagle says the decision was "incorrect." The drug was approved late last year for chronic lymphocytic leukemia and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma. Release

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