Biotech Values

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A Hole in One? Eagle Sues FDA Over BENDEKA Orphan Drug Exclusivity in Depomed-like Lawsuit
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2016/04/a-hole-in-one-eagle-sues-fda-over-bendeka-orphan-drug-exclusivity-in-depomed-like-lawsuit.html

On April 27, 2016, Eagle Pharmaceuticals, Inc. (“Eagle”) filed a Complaint in the U.S. District Court for the District of Columbia alleging that FDA violated the Administrative Procedure Act (“APA”) when the Agency refused to grant periods of 7-year orphan drug exclusivity upon the December 7, 2015 approval of Eagle’s 505(b)(2) NDA 208194 for BENDEKA (bendamustine HCl) Injection, 100 mg/4 mL (25 mg/mL) for both the treatment of patients with Chronic Lymphocytic Leukemia (“CLL”) and for the treatment of 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. http://www.fdalawblog.net/BENDEKA%20-%20Eagle%20Complaint.pdf

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