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.

Aclasta, the drug manufactured by Novartis for the treatment of osteoporosis has received approval from the European Commission for use in men facing a high risk of fractures. Along with that, the Aclasta label has been broadened by EU to include reduction of new clinical fractures in men as well as post-menopausal women suffering from osteoporosis, who had a hip fracture recently. Known as Reclast in the United States, the once-yearly drug belongs to the category of medicines called bisphosphonates that boost bone mass, reducing fracture risk in osteoporosis patients.