December 11, 2013 7:45 a.m. to 5:00 p.m.: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement.
December 11, 2013 7:45 a.m. to 5:00 p.m.: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
FDA White Oak Campus
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
The committee will discuss the safety and efficacy of biologic licensing application (BLA) 125390, metreleptin for injection, sponsored by Amylin Pharmaceuticals, LLC, a wholly owned subsidiary of Bristol Myers Squibb. The proposed indication for metreleptin is the treatment of metabolic disorders associated with lipodystrophy, including diabetes mellitus and/or hypertriglyceridemia (elevated triglyceride levels in the blood) in pediatric and adult patients with inherited or acquired lipodystrophy. (Lipodystrophies are rare medical conditions of abnormal loss of the body’s fatty tissues.)
Please click HERE for the current roster of the Endocrinologic and Metabolic Drugs Advisory Committee.
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