Tuesday, January 16, 2007 8:48:39 AM
7:37 AM EST January 16, 2007
DOW JONES NEWSWIRES
Tercica Inc. (TRCA) said its partner Ipsen (1025915.FR) received notice from the Food and Drug Administration that the agency has accepted the company's new drug application for a 28-day sustained-release formulation of Somatuline Autogel, a treatment for acromegaly, a disease caused by an excess of human-growth hormones.
Tercica, a Brisbane, Calif., biopharmaceutical company, said Tuesday it expects the FDA to complete its review by Aug. 30.
The new drug application covers 60-, 90- and 120-milligram sustained-release Somatuline Autogel injections.
As of Dec. 31, 2005, Somatuline and Somatuline Autogel had marketing approval in more than 50 countries.
-James DeWeese; 201-938-5400; AskNewswires@dowjones.com
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