15 July 2016 - Elite Pharmaceuticals today announced that the U.S. FDA has issued a complete response letter (the regarding the new drug application for SequestOx (oxycodone hydrochloride and naltrexone hydrochloride), 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.

"We are evaluating the complete response letter received and hope to meet as soon as possible with the FDA to discuss how to address their concerns. We will work closely with the FDA to determine the appropriate next steps and path forward for the new drug," said Nasrat Hakim, President and CEO of Elite.

After the Company has met with the FDA and the Agency is able to provide greater clarity to the issues raised in the CRL, Elite will host a conference call to discuss the pathway forward for SequestOx.

View Elite Pharmaceuticals press release