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PHARMA - INCRELEX

Insmed files against Increlex approval

 

BY OUR PHARMA CORRESPONDENT

17th August,2005: Insmed Incorporated has filed a Citizen Petition to deny approval of Tercica's NDA for Increlex with immediate effect. Upon inquiry, the U.S. Food & Drug Administration informed Tercica that the content of the Citizen Petition will be made available publicly in approximately three days, Tercica, Inc announced. 

"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." 

Tercica, Inc. is a biopharmaceutical company focused on the development and commercialization of products to improve endocrine health. The company's first product candidate, Increlex (mecasermin (rDNA origin) injection), or recombinant human insulin-like growth factor-1 (rhIGF-1), is being developed for the treatment of short stature and associated metabolic disorders.

BY OUR PHARMA CORRESPONDENT
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