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IPlex Approval History

FDA Approved: Yes (First approved December 12, 2005)
Brand name: iPlex
Generic name: mecasermin rinfabate [rDNA origin]
Dosage form: Injection
Previous Name: SomatoKine
Company: Insmed Incorporated
Treatment for: Primary IGF-1 Deficiency

iPlex (mecasermin rinfabate) is the human recombinant of the naturally occurring protein complex of insulin-like growth factor-I (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3). iPlex is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

Development History and FDA Approval Process for iPlex

DateArticle
Dec 12, 2005Approval iPlex Insmed Incorporated - Treatment for Severe Primary IGF-1 Deficiency
Oct 25, 2005FDA to Review Insmed's Complete Response to Approvable Letter for iPlex
Oct 17, 2005Insmed Submits Response to FDA Approvable Letter for iPlex
Sep 27, 2005Insmed Receives Approvable Letter for iPlex
Jun 10, 2005FDA Extends PDUFA Date for SomatoKine to October 3, 2005
Mar 10, 2005FDA Accepts for Review Insmed's NDA for SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome
Jan  3, 2005Insmed Submits New Drug Application -NDA- to Seek Regulatory Approval of SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome

Further information

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