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BRAEBURN INC. v. UNITED STATES FDA

Civil Action No. 19-982 (BAH).

389 F.Supp.3d 1 (2019)

BRAEBURN INC., Plaintiff, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants, and Indivior Inc., Intervenor-Defendant.

United States District Court, District of Columbia.

Signed July 22, 2019.

Editors Note
Applicable Law: 05 U.S.C. § 0706
Cause: 05 U.S.C. § 0706 Judicial Review of Agency Actions
Nature of Suit: 890 Other Statutory Actions
Source: PACER

Attorney(s) appearing for the Case

Brian Burgess , William M. Jay , Goodwin Procter LLP, Prescott Moore Lassman , Lassman Law+ Policy, Washington, DC, Gerard Justin Cedrone , Sarah K. Frederick , Goodwin Procter LLP, Boston, MA, for Plaintiff.

Roger Joseph Gural , U.S. Department of Justice, Washington, DC, for Defendant.

Michael D. Shumsky , Kurt R. Karst , Sara Wexler Koblitz , Hyman, Phelps & McNamara, P.C., Washington, DC, for Intervenor Defendant.

MEMORANDUM OPINION

Both the plaintiff, Braeburn Inc., and the intervenor-defendant, Indivior Inc., are pharmaceutical companies that manufacture drug products using buprenorphine, a safer alternative to methadone, to treat moderate-to-severe opioid use disorder ("OUD"). All parties recognize...

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