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Catalyst

Slingshot members are tracking this event:

REMOXY PDUFA Date of September 25, 2016

Source Link:: http://phx.corporate-ir.net/phoenix.zhtml?c=121590&p=irol-newsArticle&ID=2156624

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Additional Information

Additional Relevant Details FDA announced that the New Drug Application for REMOXY, an abuse-deterrent formulation of extended-release oxycodone (CII) capsules, is sufficiently complete to permit a substantive review, and that September 25, 2016 is the target action date under the Prescription Drug User Fee Act (PDUFA).

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Additional Relevant Details The FDA has determined that an Advisory Committee meeting for REMOXY, which had been tentatively scheduled forAugust 5, 2016, is unnecessary and will not be held.

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Catalyst Date

Occurred on:

Sep 26, 2016

Occurred Source:

http://phx.corporate-ir.net/phoenix.zhtml?c=121590&p=irol-newsArticle&ID=2205826

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Related Keywords Remoxy, Pdufa, Oxycodone Capsules