Cadence Pharmaceuticals (NASDAQ: [[ticker:CADX]]), the San Diego-based developer of a pain reliever for use in hospitals, said today it has re-submitted its new drug application for the IV form of acetaminophen (Ofirmev) to the FDA. The company’s earlier application was delayed on February 10, when the FDA said it found deficiencies on an inspection of a third-party manufacturer. Cadence said it met with the FDA on April 16 to discuss the deficiencies found in the letter, and the agency didn’t require any new studies.
Author: Luke Timmerman
Luke is an award-winning journalist specializing in life sciences. He has served as national biotechnology editor for Xconomy and national biotechnology reporter for Bloomberg News. Luke got started covering life sciences at The Seattle Times, where he was the lead reporter on an investigation of doctors who leaked confidential information about clinical trials to investors. The story won the Scripps Howard National Journalism Award and several other national prizes. Luke holds a bachelor’s degree in journalism from the University of Wisconsin-Madison, and during the 2005-2006 academic year, he was a Knight Science Journalism Fellow at MIT.
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