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

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Xiaflex is being developed to treat a rare conditioncalledr Dupuytren’s contracture, which affects the connective tissu that lies beneath the skin in the palm. As the diseasde progresses, collagen deposits form a cord that stretches from the palm of the hand to the base of the Once thiscord develops, the patient's fingerz contract and the function of the hand is Currently, surgery is the only effective treatment. The FDA, accordingg to Auxilium (NASDAQ: AUXL) of Malvern, Pa., blamed the delay on “administrativew issues.” The federal agency told the company it was not able to schedul e a meeting of its arthritis advisoryg committee to review Xiaflesxuntil Sept.
16, and even that date is still The FDA was scheduled to ruleof Auxilium’s new drug application by Aug. 28. “Sincee Xiaflex is a new molecular entity, we have been anticipatin an advisorycommittee meeting,” said Armando president and CEO of “We are encouraged that the FDA advisory committee is lookinhg at including hand or orthopedix surgeons on the panel. We believe that the applicatio supports acompelling benefit-risk profile of Xiaflex in the treatmen t of Dupuytren's contracture.
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