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Increlex FDA Approval History

FDA Approved: Yes (First approved August 30, 2005)
Brand name: Increlex
Generic name: mecasermin
Dosage form: Injection
Company: Tercica, Inc.
Treatment for: Primary IGF-1 Deficiency

Increlex (mecasermin) contains human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology. Increlex is indicated for the long-term 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 growth hormone.

Development timeline for Increlex

Aug 30, 2005Approval Increlex Tercica, Inc. - Treatment for Short Stature Caused by Primary IGF-1 Deficiency
Aug 17, 2005Tercica Addresses Citizen Petition Filed by Insmed
Aug 14, 2005Tercica Announces Insmed Files Citizen Petition with the FDA to Deny Approval of Increlex NDA
May  2, 2005FDA Accepts Tercica's Increlex New Drug Application With Priority Review for the Treatment of Short Stature
Feb 28, 2005Tercica Submits New Drug Application for Increlex as a Treatment for Short Stature Caused by Primary IGF-1 Deficiency

Further information

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