Insmed Incorporated has filed a Citizen Petition to immediately deny approval of Tercica's NDA for Increlex. Upon inquiry, the US Food & Drug Administration informed the company that the content of the Citizen Petition will be made available publicly in approximately three days, Tercica, Inc. announced here.
"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, president and CEO of Tercica. "Tercica has received no communication from the FDA regarding how this Citizen Petition will affect the Increlex NDA, if at all," he added.