Indivior (LON:INDV) said today that the FDA accepted the new drug application for its once-monthly injectable buprenorphine depot as a treatment for adults with opioid use disorder.
The regulatory agency also granted priority review designation to the company’s NDA. Indivior’s application was supported by data from a pivotal Phase III trial, which evaluated the safety and efficacy of RBP-6000.
Get the full story at our sister site, Drug Delivery Business News.
The post FDA grants priority review to Indivior’s monthly buprenorphine depot appeared first on MassDevice.
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