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FDA won't meet action data for updated labeling for pain med Xtampza ER; shares down 7% premarket

Published 11/06/2017, 09:07 AM
© Reuters.  FDA won't meet action data for updated labeling for pain med Xtampza ER; shares down 7% premarket
COLL
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  • Collegium Pharmaceutical (NASDAQ:COLL) slips 7% premarket, albeit on only 274 shares, on the heels of its announcement that the FDA will not meet its action date (PDUFA) regarding its supplemental New Drug Application (sNDA) to enhance the label of abuse-deterrent opioid Xtampza ER (oxycodone extended-release).
  • CEO Michael Heffernan says the agency has not requested any additional scientific information or data so the nature of the delay is unclear at present.
  • Now read: MannKind Scripts Rebound - Why The Equity Is Volatile


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