IPlex
Generic name: mecasermin rinfabate [rDNA origin]
Treatment for: Primary IGF-1 Deficiency
Insmed Submits Response to FDA Approvable Letter for iPlex
RICHMOND, Va., October 17, 2005 -- Insmed Incorporated announced today that it has submitted its response to the Approvable Letter received from United States Food and Drug Administration (FDA) for iPlex(TM) (rhIGF-I/rhIGFBP-3) (Mecasermin rinfibate), for the treatment of children with growth failure who suffer from Severe Primary IGF-1 deficiency (Primary IGFD).
In September 2005, the FDA issued an Approvable Letter indicating that the FDA has completed the review of the iPlex NDA and has found the application to be sufficiently complete for full approval pending the submission of additional information primarily regarding the Chemistry, Manufacturing and Controls (CMC) section of the application. The Company believes that its response addresses all issues noted in the Approvable Letter. FDA is not requiring the Company to conduct additional preclinical or clinical trials. The Company looks forward to working with the Agency as they continue the evaluation of the iPlex New Drug Application (NDA).
Source: Insmed Incorporated
Posted: October 2005
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IPlex (mecasermin rinfabate [rDNA origin]) FDA Approval History
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