On May 16, 2018 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported that the U.S. Food and Drug Administration (FDA) has granted final approval for Eagle’s ready-to-dilute (RTD) bendamustine hydrochloride (HCl) solution in a 500ml admixture for the treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen (Press release, Eagle Pharmaceuticals, MAY 16, 2018, View Source [SID1234526686]). Eagle’s bendamustine HCl injection does not require reconstitution and is administered as a 500ml admixture over 30 or 60 minutes.
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"This approval expands our bendamustine product offering, is complementary to BENDEKA, and enables us to provide value to a cost-conscious segment of the market that we are uniquely positioned to fill. We intend to launch our ready-to-dilute product with our internal sales force. Based upon our view of the market, we anticipate over time achieving up to a 12% market share, increasing our overall profitability," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
Eagle has 13 U.S. patents covering different bendamustine formulations and methods.