iPlex
mecasermin rinfabate [rDNA origin]
Treatment for Primary IGF-1 DeficiencyFDA Extends PDUFA Date for SomatoKine to October 3, 2005
RICHMOND, Va., June 10, 2005 - Insmed Incorporated (NASDAQ: INSM) today announced that it has received notification from the United States Food and Drug Administration (FDA) that the agency expects to complete the priority review of SomatoKine on or before October 03, 2005, which is a three month extension from the original user fee goal date.
The extension is a result of the agency classifying responses to questions about the NDA as a major amendment to the NDA. The agency has reset the user fee goal date to give it additional time to review the information contained in the Company's response.
"We welcomed the opportunity to address questions the FDA had regarding our NDA," said Geoffrey Allen, President and CEO of Insmed. "The Company has not been notified of any specific deficiencies and we believe we have thoroughly and comprehensively addressed all of their questions. We remain confident that SomatoKine will become an important therapy for the treatment of growth hormone insensitivity syndrome (GHIS).
About Insmed Incorporated
Insmed is a biopharmaceutical company focused on the discovery and
development of drug candidates for the treatment of metabolic
diseases and endocrine disorders with unmet medical needs.
For more information, please visit the Insmed website.
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FDA Accepts for Review Insmed's NDA for SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome - March 10, 2005
Insmed Submits New Drug Application -NDA- to Seek Regulatory Approval of SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome - January 3, 2005
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