The USFDA has granted tentative approval to MDRNA's 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 is the generic equivalent of Miacalcin marketed by Novartis Pharmaceuticals Corporation. US sales of Miacalcin were approximately $147 million in 2007. On December 23, 2003, FDA accepted for filing MDRNA's 505(j) paragraph 4 ANDA for the product. In October 2004, MDRNA and Par Pharmaceutical Companies, Inc. entered into an exclusive license and supply agreement for US distribution and marketing of the product. Under terms of the agreement, MDRNA is responsible for obtaining regulatory approval and manufacturing, and will receive product transfer payments for manufactured product and profit sharing following commercialization.
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