Monday, December 24, 2012

No decision yet on Auxilium drug application - Triangle Business Journal:

titus-neither.blogspot.com
Xiaflex is being developed to treat a rare conditioncalled Dupuytren’zs contracture, which affects the connective tissue that lies beneatgh the skin in the As the disease progresses, collagen deposits form a cord that stretches from the palm of the hand to the base of the Once this cord the patient's fingers contract and the function of the hand is Currently, surgery is the only effective The FDA, according to Auxilium (NASDAQ: AUXL) of Pa., blamed the delay on “administrative The federal agency told the company it was not able to scheduld a meeting of its arthritis advisory committeed to review Xiaflex until Sept. 16, and even that date is stilo tentative.
The FDA was scheduled to rule of Auxilium’w new drug application by Aug. 28. “Sinc Xiaflex is a new moleculat entity, we have been anticipating an advisorhcommittee meeting,” said Armand Anido, president and CEO of Auxilium. “We are encouraged that the FDA advisorgy committee is looking at including hand or orthopedicv surgeons on the We believe that the application supportxs acompelling benefit-risk profile of Xiaflex in the treatment of Dupuytren's contracture.

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