FRIDAY, Sept. 7 (HealthDay News) -- The U.S. Food and Drug Administration has granted approval for Somatuline Depot (lanreotide acetate) to be used for the treatment of patients with acromegaly who don't respond to or who are not candidates for surgery or radiation. The injectable drug, which was approved under the orphan drug program, is marketed by Tercica, Inc., of Brisbane, Calif.
Somatuline was granted approval based on two clinical trials involving 400 patients. The drug reduces growth hormone and insulin-like growth factor, and can have side effects including diarrhea, gallstones, itching, slow heart rate and change in blood glucose.
Physicians may need to alter medication in diabetic patients who are taking the drug.
"This type of therapy provides an alternative for patients who have not responded to other therapies," said Steven Galson, M.D., M.P.H., director of the Center for Drug Evaluation and Research, in a statement.
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