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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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