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FDA approves Myalept, but includes a heavy postmarketing burden

By Marie Powers
Staff Writer

Tuesday, February 25, 2014
Metreleptin, the biologic developed by Bristol-Myers Squibb Co.’s (BMS) wholly owned subsidiary Amylin Pharmaceuticals LLC, received an FDA green light on its PDUFA date of Feb. 24 as a replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with ultra-rare congenital generalized or acquired generalized lipodystrophy (LD).

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