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Re: mrwrn2010 post# 386735

Wednesday, 08/30/2023 11:27:41 AM

Wednesday, August 30, 2023 11:27:41 AM

Post# of 401374
It's a more unique situation so the PDUFA date may be listed similar to SequestOx:

NORTHVALE, N.J. – March 17, 2016 – 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.

The antimetabolite and dopamine agonist are just standard run-of-the-mill generics and the PDUFA dates are never listed.

Thanks.

Don’t think the PDUFA date is listed in the press release. At least it hasn’t been for the last 2 they told us about - the antimetabolite or the dopamine agonist.

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