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FDA relents on Brixadi, competitor to Sublocade
Author(s) -
Knopf Alison
Publication year - 2019
Publication title -
alcoholism and drug abuse weekly
Language(s) - English
Resource type - Journals
eISSN - 1556-7591
pISSN - 1042-1394
DOI - 10.1002/adaw.32541
Subject(s) - food and drug administration , orphan drug , buprenorphine , business , advertising , medicine , risk analysis (engineering) , opioid , bioinformatics , receptor , biology
Last week, Braeburn won its fight against Indivior to bring its injectable form of buprenorphine, Brixadi, to the U.S. market. The Food and Drug Administration (FDA) granted Braeburn's request to the FDA to revoke the orphan drug designation for Indivior's Sublocade. However, the FDA has reaffirmed exclusivity for Sublocade until next November.