FDA Approves Somatuline Depot for Acromegaly

On August 31, 2007, the US Food and Drug Administration (FDA) approved Somatuline depot (lanreotide acetate injection) 60, 90, and 120 mg for marketing in the United States. Somatuline depot, manufactured by Tercica, Inc. (Brisbane, CA, www.tercica.com), is indicated for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery or radiotherapy, or for whom surgery or radiotherapy is not an option. Somatuline depot will be available in a pre-filled syringe eliminating the need for reconstitution. Somatuline depot is expected to launch in the United States in the fourth quarter 2007.