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 MiacalcinĀ® marketed by Novartis Pharmaceuticals Corporation. U.S. sales of MiacalcinĀ® were approximately $147 million in 2007.
