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Orphan Drug Designation and Exclusivity for “Same Drugs”

Published online by Cambridge University Press:  01 January 2021

Abstract

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Type
Columns: Health Policy Portal
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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References

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).+(last+visited+April+28,+2019).>Google Scholar
21 U.S.C. § 360cc(a) (2012).Google Scholar
21 C.F.R. § 316.3(b)(12) (2018).CrossRefGoogle Scholar
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).+(last+visited+May+3,+2019);+Food+and+Drug+Administration,+Treanda+Prescribing+Information,+available+at++(last+visited+May+3,+2019).>Google Scholar
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).+(last+visited+April+28,+2019).>Google Scholar
Bendeka Prescribing Information, supra note 4.Google Scholar
Eagle Pharms., Inc. v. Azar, No. 16-790, ECF No. 64 (D.D.C. 2018).Google Scholar
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).Google Scholar
Certain Products Containing Bendamustine, supra note 5.Google Scholar
Teva Pharm., Annual Report (Form 10-K) (Mar. 26, 2019).Google Scholar
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).+(last+visited+April+28,+2019).>Google Scholar

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