FDAnews Drug Daily Bulletin

FDA Calls for Further Studies for Intellipharmaceutics’ Rexista

Sept. 28, 2017

The FDA sent Intellipharmaceutics a complete response letter for Rexista — an extended-release oxycodone tablet rejected in July by an FDA advisory committee — calling for additional studies of the drug’s abuse-deterrent properties.

In the letter responding to the drugmaker’s NDA, the agency recommended completion of Category 2 and Category 3 clinical studies to assess abuse deterrence when taken orally and nasally, and asked for more information on the blue dye used in the drug formulation to deter abuse.

The agency also called for an alternate proposed proprietary name for the drug.

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