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FDA Accepts ANDA Filing for Calcitonin-Salmon Nasal Spray
"We are pleased with the FDA's acceptance of this ANDA filing for an important Nastech product. While we await the FDA's action, we are working to ensure that the necessary marketing and distribution arrangements are in place," stated Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech.
Calcitonin is a polypeptide hormone. Endogenous calcitonin is produced in the parafollicular cells of the thyroid gland of humans. Salmon calcitonin is 40-50 times more potent and has a longer duration of action than human calcitonin. Calcitonin prevents bone loss and fractures and increases bone density in patients with osteoporosis. Calcitonin-Salmon Nasal Spray is used for the treatment of postmenopausal osteoporosis in females and is appropriate in patients in whom estrogens are contraindicated.
Source: Nastech Pharmaceutical Company Inc.