FDA approves label update for Xiaflex
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Endo Pharmaceuticals recently announced the FDA has approved a label update for Xiaflex to include the treatment of Dupuytren’s contracture.
Patients indicated for treatment with Xiaflex are those with Dupuytren’s who have a palpable cord. The update comes on the heels of a long-term observational study demonstrating diminished recurrence of Dupuytren’s for up to 5 years when treated with Xiaflex, according to a company press release.
“The FDA’s initial approval of Xiaflex more than 5 years ago brought an effective, non-surgical and minimally invasive option for the treatment of adult [Dupuytren’s] patients,” Sue Hall, PhD, Endo’s executive vice president, chief scientific officer, and global head of research and development and quality, said in the release. “The updated label that includes data in patients with recurring contractures coupled with the 5-year follow-up data in previously-treated patients further supports the efficacy and safety of Xiaflex for initial and retreatment of [Dupuytren’s] patients.”
Reference: www.endo.com.