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BRAEBURN INC. v. UNITED STATES FOOD AND DRUG ADMINISTRATION et al
Case Number:
1:19-cv-00982
Court:
Nature of Suit:
Judge:
Firms
Companies
Government Agencies
Sectors & Industries:
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July 23, 2019
FDA Must Reconsider Denial Of Braeburn Anti-Opioid Drug
A D.C. federal judge on Monday tossed a U.S. Food and Drug Administration decision that blocked a Braeburn Inc. drug that fights opioid-addiction from reaching the market, saying the agency needs to take another look at whether a rival drug's exclusivity barred final approval of Braeburn's.
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June 05, 2019
FDA, Indivior Say Braeburn Fibbing In Opioid Exclusivity Suit
The U.S. Food and Drug Administration and Indivior Inc. are accusing Braeburn Inc. of exaggerating the science behind its opioid-addiction drug Brixadi in hopes of starting sales that are blocked by exclusivity for a rival drug marketed by Indivior.
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April 09, 2019
FDA Exclusivity View Blocking Opioid Treatment, Suit Says
The U.S. Food and Drug Administration's overbroad exclusivity for an Indivior Inc. drug that treats opioid addiction is blocking a Braeburn Inc. drug that would further expand treatment, Braeburn said in a lawsuit filed Tuesday in D.C. federal court.