Elite Pharmaceuticals provides update on SequestOx NDA
Elite Pharmaceuticals announced the company met with the FDA on December 21, 2016 for an end-of-review meeting to discuss steps that Elite can take to obtain approval of SequestOx. Based on the FDA response, the company believes there is a clear path forward to address the issues cited in the July 14th Complete Response Letter. The FDA will provide minutes of the meeting by the end of January and the company will issue a further update at that time. SequestOx is Elite's investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. The proposed plan submitted by the company addresses items cited in the CRL dated July 14, 2016 for the New Drug Application for SequestOx.