Catalyst

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Endo International(ENDP) will submit a supplemental request for labeling that will potentially add their abuse deterrent formulation claim to protected intellectual property

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ENDP

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Additional Information

Additional Relevant Details
In parallel, and following our discussions with the FDA earlier this year, we expect to submit a supplemental request for labeling that will potentially add abuse-deterrent formulation claims. We expect to file that request in late 2015 or early 2016.
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Catalyst Date
Occurred on:
Aug 12, 2016
Occurred Source:
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Related Keywords Abuse Deterrent, Supplemental Request, Pain Management, Mystery Products