* Says to resubmit NDA within next 30 days
* Says FDA did not request data on stability studies
* Shares up 13 percent
April 19 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
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