http://www.pharmaceuticalproductguide.com/blog A comprehensive guide to pharmaceutical products for medical professionals Fri, 11 Jun 2010 09:15:33 +0000 http://wordpress.org/?v=2.8.2 en hourly 1 http://www.pharmaceuticalproductguide.com/blog/2008/12/18/mdrna-announces-tentative-fda-approval-of-generic-calcitonin-salmon-nasal-spray/ http://www.pharmaceuticalproductguide.com/blog/2008/12/18/mdrna-announces-tentative-fda-approval-of-generic-calcitonin-salmon-nasal-spray/#comments Thu, 18 Dec 2008 12:08:04 +0000 Kimberly O'Brien http://www.pharmaceuticalproductguide.com/blog/2008/12/18/mdrna-announces-tentative-fda-approval-of-generic-calcitonin-salmon-nasal-spray/ MDRNA, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval of MDRNA’s Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray for the treatment of osteoporosis. Full FDA approval would follow the completion of Apotex’s 180-day exclusivity period, or June 2009. MDRNA’s generic calcitonin-salmon nasal spray, a legacy product developed by MDRNA in the early 2000s, is the generic equivalent of Miacalcin® marketed by Novartis Pharmaceuticals Corporation. U.S. sales of Miacalcin® were approximately $147 million in 2007.

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