Pharmaceutical Business review

MDRNA Wins FDA Approval For Generic Calcitonin-Salmon Nasal Spray

MDRNA announced that it has obtained full FDA approval of its Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray for the treatment of osteoporosis.

Calcitonin-salmon nasal spray, a product developed by MDRNA in the early 2000s, is the generic equivalent of Miacalcin nasal spray, marketed by Novartis.

J. Michael French, President and CEO of MDRNA, said: We are pleased that generic calcitonin-salmon nasal spray has received full FDA approval and has been launched by Par,

Revenue generated from the sale of calcitonin-salmon by Par will provide us with working capital to help advance our RNAi programs. I thank the team at MDRNA and Par for their superb efforts to bring this product to market, he added.