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Indivior Gets FDA Priority Review on Prior Approval Supplement for Sublocade
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Indivior Gets FDA Priority Review on Prior Approval Supplement for Sublocade
Oct 7, 2024 9:56 AM

12:38 PM EDT, 10/07/2024 (MT Newswires) -- Indivior ( INDV ) said Monday that the US Food and Drug Administration granted priority review designation to prior approval supplement for Sublocade injection.

Sublocade is a monthly injectable formulation of buprenorphine from Indivior ( INDV ) for moderate to severe opioid use disorder treatment.

The FDA has set a prescription drug user fee act target action date of Feb. 7, according to the company.

Indivior ( INDV ) said the prior approval supplement for Sublocade is looking to expand use with alternative injection sites and the rapid induction protocol, which reduces induction time on transmucosal buprenorphine from seven days to a single dose with a one-hour observation period and allows for a second injection dose as early as one week.

Price: 10.33, Change: -0.09, Percent Change: -0.86

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