Shares of Cadence Pharmaceuticals Inc. climbed Monday after the company said it plans to make a new request for approval of its pain and fever drug Ofirmev within the next 30 days.
Cadence said it expects the Food and Drug Administration to make a decision on the drug within three to six months of the new submission. The agency declined to approve Ofirmev in February because of problems at the facility where the drug was made.
Cadence said it met with the FDA and with its third-party manufacturer on Friday. The agency did not ask for any new information or studies about Ofirmev, which is an injectable form of acetaminophen.
The FDA will determine the length of the review, assigning either a three-month or six-month deadline. Cadence said it is working with the manufacturer to make sure the problems with Ofirmev are resolved.
In afternoon trading, shares of the San Diego company rose $1.29, or 14 percent, to $10.48. The stock has ranged from $8.25 to $12.68 over the past year.