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US FDA Must Explain How It Defines ‘Innovation’ In Awarding Hatch/Waxman Exclusivity, Court Says

 
• By Sue Sutter

Agency's decision that Indivior’s Sublocade blocked Braeburn’s long-acting buprenorphine formulation Brixadi lacked ‘substantive guideposts’ in how innovation is defined for purposes of deciding scope of three-year exclusivity, US judge says.

Boxing-ring-bell
Round 1 goes to Braeburn in its legal boxing match with the FDA and Indivior over Brixadi. • Source: Shutterstock

The US Food and Drug Administration must set forth a standard by which a drug’s “innovation” is defined in determining whether Hatch/Waxman new product exclusivity blocks approval of a subsequent product, a US federal judge has ruled in a dispute related to buprenorphine depot injection formulations.

The agency’s decision that the monthly formulation of Braeburn Pharmaceuticals Inc

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