By Pat Anson, Editor
The Food and Drug Administration has notified Zogenix Inc. (NASDAQ: ZGNX) that it will soon make a final decision on the company’s powerful new painkiller, Zohydro.
In a statement, the San Diego-based company said an FDA action letter on the New Drug Application (NDA) for Zohydro could be made “after a further delay of short duration.”
The FDA had previously said an action letter would be released this summer. Not only did the agency fail to meet that timetable, but it could now encounter further delays due to the government shutdown over the Affordable Care Act.
“Zogenix and the FDA have completed the final labeling and reached agreement on the post-marketing requirements for Zohydro ER. The FDA has also reconfirmed there are no deficiencies in the NDA. While the FDA indicated its intent to take prompt action on the Zohydro ER NDA, the timing for a decision may be impacted by the current federal government shutdown,” the company said.
If approved, Zohydro would be the first pure hydrocodone painkiller sold in the U.S. Combination versions of hydrocodone, such as Vicodin, typically contain acetaminophen and require dosing every 4 to 6 hours. Extended release Zohydro could be taken just twice a day.
Read more at National Pain Report.
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