About Eagle Pharmaceuticals, Inc. Eagle is a specialty pharmaceutical company focused on the development and marketing of injectable products that correct deficiencies identified by physicians, pharmacists and other stakeholders in successfully marketed products. Eagle`s strategy is to use the 505 (b) (2) FDA regulatory pathway. Eagle currently markets RYANODEX® (Dantrolen-sodium) in the United States for the treatment of malignant hyperthermia. For more information, please visit the company`s website at www.eagleus.com. In accordance with BENDEKA`s exclusive February 2015 licensing agreement, Teva is responsible for all U.S. business activities for the product, including promotion and distribution. Teva expects BENDEKA to be commercially available to prescribers in the first quarter of 2016. This press release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other securities laws. Forward-looking statements are statements that are not historical facts.
Words such as “will,” “may,” “intends,” “anticipate (s), “plan,” “enables,” “potentially,” “legitimate” and similar expressions must identify forward-looking statements. These statements include, but are not limited to statements about future events, including, but not limited to: acceptance for FDA submission of NDA for the Bendamustine rapid infusion product for the treatment of patients with LLL and patients with indolent B-Zell-NHL, which is advanced during or within six months of treatment with rituximab or a rituximab diet; FDA`s decision on Eagle`s request for priority review for this NDA; successful FDA approval of bendamustine rapid infusion product for the treatment of LLL patients and patients with indulging NHL B who have progressed during or within six months of treatment with rituximab or a rituximab-containing treatment system; the timing and success of a future product release for Teva`s rapid infusion of Bendamustine; the success of Eagle`s trade agreement with Teva and the ability of the parties to cooperate effectively; difficulties or delays in manufacturing; Availability and pricing of products and materials from third parties; Effective compliance with the FDA and other regulatory rules for production facilities, products and/or businesses; and other factors that will be considered in Eagle`s Management Report on Form 10-K for the year past September 30, 2014 and its other notifications in the United States.