July 27, 2017 / 12:27 AM / in 3 months

BRIEF-Intellipharmaceutics says committees expressed desire to review additional safety data for Rexista

July 26 (Reuters) - Intellipharmaceutics International Inc

* Intellipharmaceutics provides update on FDA advisory committees meeting for Rexista™ (oxycodone hydrochloride extended release), an abuse-deterrent opioid analgesic for the treatment of moderate to severe pain

* Intellipharmaceutics - Committees expressed desire to review additional safety data for Rexista

* Intellipharmaceutics International Inc - Intends to conduct category 3 abuse potential studies for Rexista(tm)

* Can be no assurance that we will not be required to conduct further studies for Rexista

* Intellipharmaceutics International - FDA set a prescription drug user fee act goal date of Sept 25 for completion of its review of Rexista NDA candidate

* Intellipharmaceutics International Inc - FDA advisory committee voted 22 to 1 in finding co’s nda for Rexista should not be approved at this time Source text for Eikon: Further company coverage:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below