Insmed files petition against Tercica

Published: 18-Aug-2005

Insmed Incorporated has filed a citizen petition in an attempt to immediately deny approval of Tercica's NDA for Increlex. Upon inquiry, the US FDA informed Tercica that the content of the petition is expected to be made public on 17 August.


Insmed Incorporated has filed a citizen petition in an attempt to immediately deny approval of Tercica's NDA for Increlex. Upon inquiry, the US FDA informed Tercica that the content of the petition is expected to be made public on 17 August.

'While we don't have access to the content of the petition, we believe it was important to disclose this development,' said John A. Scarlett, md, president and ceo of Tercica. 'Tercica has received no communication from the FDA regarding how the petition will affect the Increlex NDA, if at all.'

Tercica is a biopharmaceutical company focused on the development and commercialisation of products to improve endocrine health. Increlex (mecasermin (rDNA origin) injection), is its first product candidate, and is being developed for the treatment of short stature and associated metabolic disorders.

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