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Ipsen’s Acromegaly NDA Accepted for Review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Ipsen’s NDA for Somatuline Autogel (60, 90, 120 mg), a 28-day sustained-release formulation to treat patients with acromegaly, has been accepted by the FDA. This acceptance initiates the start of the review process of the NDA with a “prescription drug user fee act” set for August 2007. Subject to approval by the FDA, Ipsen’s partner Tercica will market Somatuline Autogel in the U.S. Acromegaly is a disorder caused by the over-production of growth hormone secondary to a benign tumor of the anterior pituitary gland.

Somatuline Autogel received a marketing approval in Canada in July 2006, and is currently being launched by Tercica under its distribution license agreement with Ipsen, holder of the product’s rights.

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