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Indivior, Braeburn, And Two Very Well-Timed Anti-Addiction Applications

US FDA advisory committee had dosing and dispensing concerns about both buprenorphine injectable products, but each ended up with a strong vote in favor, clearly benefiting from public health attention to opioid addiction and the call for broader access to treatment.

Balancing time and money
Applying at the right time can outweigh a lot of an NDA's shortcomings.

Halloween probably feels like an ominous time for a sponsor with an important new drug application to go before a US FDA advisory committee. At the very least, it is an inconvenient date for any parents of Trick-or-Treat-age children.

But for Indivior PLC and Braeburn Pharmaceuticals Inc., it is hard to imagine a better-timed advisory committee meeting...

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