1. Pink Sheet

US FDA’s Transfer Policy For Orphan Drug Designation Under Scrutiny

 
• By Sue Sutter

Braeburn Pharmaceuticals says awarding Indivior’s opioid use disorder treatment Sublocade seven-year orphan exclusivity that flows from a 1994 orphan drug designation for Subutex would be an abuse of the system. The US FDA said it is carefully considering whether Sublocade qualifies for exclusivity ‘within the context of the opioid public health emergency.’

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The US FDA’s approach to transferring orphan drug designation from a sponsor’s original product to a follow-on formulation is under scrutiny in the face of the opioid crisis.

In an April 5 citizen petition, Braeburn Pharmaceuticals Inc. requests the FDA revoke orphan drug designation for Indivior PLC’s Sublocade, a long-acting depot formulation of buprenorphine, for the treatment of opioid addiction

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