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Friday, May 13, 2016 12:37:36 PM
NORTHVALE, N.J., March 17, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB:ELTP) today announced that the New Drug Application (NDA) for SequestOXTM (ELI-200), Elite’s lead opioid abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate, has been accepted and granted priority review by the United States Food and Drug Administration (“FDA”). The FDA has set a target action date under the Prescription Drug User Fee Act (“PDUFA”) of July 14, 2016.
SequestOxTM is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone which incorporates 5 mg, 10 mg, 15 mg, 20 mg and 30 mg doses of oxycodone into capsules.
“The FDA’s decision to grant Priority Review to the SequestOxTM submission is an important milestone for Elite and an important step toward providing a new treatment option for physicians and patients that may deter some of the common methods of opioid abuse,” said Nasrat Hakim, President and Chief Executive Officer of Elite. “I am pleased with the targeted PDUFA date and we look forward to the FDA’s review of our submission.”
I think that we will just leave it up to the FDA to make the determination and bypass your speculations.
SequestOxTM is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone which incorporates 5 mg, 10 mg, 15 mg, 20 mg and 30 mg doses of oxycodone into capsules.
“The FDA’s decision to grant Priority Review to the SequestOxTM submission is an important milestone for Elite and an important step toward providing a new treatment option for physicians and patients that may deter some of the common methods of opioid abuse,” said Nasrat Hakim, President and Chief Executive Officer of Elite. “I am pleased with the targeted PDUFA date and we look forward to the FDA’s review of our submission.”
I think that we will just leave it up to the FDA to make the determination and bypass your speculations.
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