Filed March 29, 2017
An entitlement to orphan drug exclusivity attaches automatically upon designation, contingent only upon approval of the drug and, according to FDA’s (unlawful) regulation, a showing of clinical superiority. See 21 U.S.C. § 360cc(a); 21 C.F.R. § 316.34(a).
Filed May 8, 2017
Case 1:16-cv-02372-ABJ Document 13 Filed 05/08/17 Page 12 of 36 6 treat patients with a rare disease, Somatuline ED earned orphan drug exclusivity under the FDCA. See 21 U.S.C. § 360cc; 21 C.F.R. § 316.31(a); Compl.