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UPDATE 1-Cadence Pharma to resubmit pain shot marketing filing
April 19, 2010 / 2:20 PM / 8 years ago

UPDATE 1-Cadence Pharma to resubmit pain shot marketing filing

* Says to resubmit NDA within next 30 days

* Says FDA did not request data on stability studies

* Shares up 13 percent

April 19 (Reuters) - Cadence Pharmaceuticals Inc CADX.O said it would resubmit the marketing application for its experimental pain injection, Ofirmev, within the next 30 days, sending its shares up as much as 13 percent.

On Feb. 11, the U.S. health regulator denied approval for the intravenous acetaminophen in its current form, citing deficiencies in a third-party manufacturer’s facility. After a meeting with the U.S. Food and Drug Administration Friday, which was classified Type A, Cadence will continue to work with its manufacturers to resolve the issues, the company said.

The FDA did not ask for additional information, including any new stability studies, Cadence said.

Shares of the company were up 13 percent at $10.37 early morning trade Monday on Nasdaq. (Reporting by Vidya L Nathan in Bangalore; Editing by Don Sebastian)

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