By Pat Anson, Editor
The Food and Drug Administration has notified Zogenix Inc. that it is unlikely to reach a decision on the company’s powerful new painkiller, Zohydro, by its March 1 target date. The move is being interpreted by some analysts as a sign that the agency might ignore the recommendation of an advisory committee and approve the use Zohydro to treat moderate to severe pain.
“The FDA has not provided the Company with information as to the reason for the possible delay, but has indicated that the delay would likely be brief and may last only several weeks. The Company has not been informed of any deficiencies in the application during the review process to date,” Zogenix (NASDAQ: ZGNX) said in a statement.
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