Acromegaly

Tercica partner Ipsen submits NDA to U.S. FDA for Somatuline Autogel for treating acromegaly

Published in Drug Law Weekly, November 28th, 2006

Tercica, Inc. (TRCA) reported that its partner Ipsen submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Somatuline Autogel (lanreotide acetate) injection 60, 90 and 120 mg to treat patients with acromegaly.

Tercica licensed from Ipsen the rights to develop and market Somatuline Autogel in the United States and Canada in a transaction that closed on October 13, 2006. The FDA will determine within 60 days whether the submission will be accepted for filing.

As of December 31, 2005, Somatuline and Somatuline Autogel had marketing authorizations in over 50 countries for the treatment of acromegaly and neuroendocrine...

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Source: Drug Law Weekly (2006-11-28)

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