This acceptance signifies the start of the review process of the new drug application with a “prescription drug user fee act” goal date set for 30 August 2007. Subject to the approval of the drug by the FDA, Ipsen’s partner Tercica will market Somatuline Autogel in the US.
Somatuline Autogel has already received a marketing approval in Canada on 17 July 2006, and is currently being launched by Tercica under its distribution license agreement with Ipsen.
Somatuline was initially developed and continues to be used in the treatment of acromegaly, a disorder caused by the over-production of growth hormone secondary to a benign tumor of the anterior pituitary gland. The drug is also approved, outside of North America, for the treatment of symptoms associated with neuroendocrine tumors.