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References
1.Food and Drug Administration , Designating an Orphan Product: Drugs and Biological Products , July 26 , 2018 , available at <https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products> (last visited April 28, 2019 ).
2.
21 U.S.C. § 360cc(a) (2012).
3.
21 C.F.R. § 316.3(b)(12) (2018).
4.Food and Drug Administration , Bendeka Prescribing Information , available at <https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208194Orig1s000Lbl.pdf> (last visited May 3, 2019 ); Food and Drug Administration, Treanda Prescribing Information, available at <https://www.access-data.fda.gov/drugsatfda_docs/label/2008/022303lbl.pdf> (last visited May 3, 2019 ).
5.Food and Drug Administration , FDA Response re Certain Products Containing Bendamustine , February 20 , 2019 , available at <https://www.regulations.gov/document?D=FDA-2018-N-3773-0024> (last visited April 28, 2019 ).
6.Bendeka Prescribing Information, supra note 4.
7.Eagle Pharms., Inc. v. Azar , No. 16-790, ECF No. 64 (D.D.C. 2018).
8.Id .
9.
FDA Reauthorization Act of 2017, Pub. L. No. 115-52, sec. 607(a), § 527(c)-(d), 131 Stat. 1005, 1049–50 (amending 21 U.S.C. § 360cc).
10.Certain Products Containing Bendamustine, supra note 5.
11.
Teva Pharm., Annual Report (Form 10-K) (Mar. 26, 2019).
12.Certain Products Containing Bendamustine, supra note 5; Food and Drug Administration , Orphan Drug Designations and Approvals , available at <https://www.accessdata.fda.gov/scripts/opdlisting/oopd/> (last visited April 28, 2019 ).