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Published online by Cambridge University Press: 06 January 2021
1 Amarin Pharma, Inc. v. U.S. Food & Drug Admin., No. 1.15-cv-3588-PAE, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015).
2 See id.
3 Complaint at 69-70, Amarin Pharma, 2015 WL 4720039 (No. 1.15-cv-3588-PAE).
4 Amarin Pharma 2015 WL 4720039, at *49.
5 See id. at 67.
6 Complaint, supra note 3, at 3.
7 Id. at 3 n.4.
8 Id. at 3.
9 Id. at 3 n.4.
10 See id. at 4.
11 Id. at 4.
12 Memorandum of Law in Opposition to Plaintiffs' Motion for Preliminary Injunction at 5, Amarin Pharma, Inc. v. U.S. Food & Drug Admin., 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015) (No. 1:15-CV-3588-PAE) [hereinafter FDA Memo].
13 Id. at 3.
14 See Complaint, supra note 3, at 19.
15 See id. at 19-20.
16 See id. at 23.
17 See id. at 3; FDA Memo, supra note 12, at 5.
18 Id. at 5.
19 Complaint, supra note 3, at 24; FDA Memo, supra note 12, at 6.
20 See FDA Memo, supra note 12, at 6.
21 Complaint, supra note 3, at 4; see FDA Memo, supra note 12, at 6.
22 Complaint, supra note 3 at 6.
23 Id. at 28.
24 See Amarin Pharma, Inc. v. U.S. Food & Drug Admin., No. 1.15-cv-3588-PAE, 2015 WL 4720039, at *2 (S.D.N.Y. Aug. 7, 2015).
25 Id. at *1.
26 See id. at *17; United States v. Caronia, 703 F.3d 149, 149 (2d Cir. 2012).
27 Caronia, 703 F.3d at 163.
28 See id.; Sorrell v. IMS Health Inc., 131 S. Ct. 2653, 2662-64 (2011).
29 Caronia, 703 F.3d at 164.
30 See Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n of N.Y., 447 U.S. 557, 566 (1980).
31 See Caronia, 703 F.3d at 168.
32 Id. (quoting Bd. of Tr. of State Univ. of N.Y. v. Fox, 492 U.S. 469, 480 (1989)).
33 Id.
34 Amarin Pharma, Inc. v. U.S. Food & Drug Admin., No. 1.15-cv-3588-PAE, 2015 WL 4720039, at *18 (S.D.N.Y. Aug. 7, 2015).
35 Id. at 47.
36 Id. at 45 (emphasis in original).
37 Id. at 49.
38 See id. at 52-53.
39 Id. at 66.
40 See id.
41 Id. at 66-67.
42 See id. at 66.
43 Id. at 67 (quoting N.Y. Progress and Prot. PAC v. Walsh, 733 F.3d 483, 488 (2d Cir. 2013)).
44 See id.
45 Id.
46 Id.
47 Id. at 67-68.
48 See Order, Amarin Pharma, Inc. v. U.S. Food & Drug Admin. 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015) (No. 1:15-cv-03588-PAE).
49 Letter to Stay Proceedings, Amarin Pharma, 2015 WL 4720039 (No. 1:15-cv-03588-PAE).
50 See id.
51 See Complaint for Declaratory and Injunctive Relief at 65-66, Pacira Pharm., Inc. v. U.S. Food & Drug Admin., 2015 WL 5256628 (S.D.N.Y Sept. 8, 2015) (No. 1:15-cv-07055-RA).
52 Id. at 72.