Skip to Content

Increlex Approval History

  • FDA approved: Yes (First approved August 30th, 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 History and FDA Approval Process 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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.