Legal Opinion

Braeburn Inc. v. United States Food and Drug Administration

District Court, District of Columbia

Decided July 22, 2019No. Civil Action No. 2019-0982Published

1Opinion of the Court

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA BRAEBURN INC., Plaintiff, Civil Action No. 19-982 (BAH) v. Chief Judge Beryl A. Howell UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants, and INDIVIOR INC., 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 the serious national public health problem posed by OUD…

2Cases cited41 opinions

  1. Lujan v. Defenders of WildlifeSupreme Court of the United States · 1992
  2. Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
  3. Spokeo, Inc. v. RobinsSupreme Court of the United States · 2016
  4. Allen v. WrightSupreme Court of the United States · 1984
  5. Bennett v. SpearSupreme Court of the United States · 1997

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