Newspaper article The Record (Bergen County, NJ)

Woodcliff Lake Firm Dealt Setback in Bid for Drug Exclusivity

Newspaper article The Record (Bergen County, NJ)

Woodcliff Lake Firm Dealt Setback in Bid for Drug Exclusivity

Article excerpt

Shares of Woodcliff Lake-based Eagle Pharmaceuticals Inc. fell Monday after the company reported that the federal Food and Drug Administration rejected its request for seven years of marketing exclusivity for a drug used to treat a form of leukemia.

"We are disappointed with the agency's decision regarding orphan drug exclusivity for Bendeka, which we believe to be incorrect," said Scott Tarriff, president and chief executive officer of the specialty pharmaceutical concern.

Bendeka, also known as bendamustine hydrochloride injection, is used to treat patients with chronic lymphocytic leukemia, as well as certain patients with indolent B-cell non-Hodgkin's lymphoma.

Eagle said it had requested seven years of orphan drug exclusivity in the United States for the injection. …

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