Increlex
Generic name: mecasermin
Treatment for: Primary IGF-1 Deficiency
Tercica Announces Insmed Files Citizen Petition with the FDA to Deny Approval of Increlex NDA
BRISBANE, Calif., August 14, 2005 -- Tercica, Inc. announced today that Insmed Incorporated has filed a Citizen Petition to immediately deny approval of Tercica's NDA for Increlex. Upon inquiry, the U.S. Food & Drug Administration informed the company that the content of the Citizen Petition will be made available publicly in approximately three days.
"While we don't have access to the content of Insmed's Citizen Petition, we believe it was important to disclose this development," said John A. Scarlett, M.D., President and Chief Executive Officer of Tercica. "Tercica has received no communication from the FDA regarding how this Citizen Petition will affect the Increlex NDA, if at all."
Posted: August 2005
Related articles
- Increlex Tercica, Inc. - Treatment for Short Stature Caused by Primary IGF-1 Deficiency - August 30, 2005
- Tercica Addresses Citizen Petition Filed by Insmed - August 17, 2005
- FDA Accepts Tercica's Increlex New Drug Application With Priority Review for the Treatment of Short Stature - May 2, 2005
- Tercica Submits New Drug Application for Increlex as a Treatment for Short Stature Caused by Primary IGF-1 Deficiency - February 28, 2005
Increlex (mecasermin) FDA Approval History
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