Nastech's oesteoporosis ANDA rejected by FDA
US drugmaker Nastech Pharmaceutical says that the Food and Drug Administration has said that its Abbreviated New Drug Application for intranasal calcitonin-salmon is "not approvable at this time." The firm added that the FDA had expressed a concern relating to the possible immunogenicity that could arise from interaction between the drug and the preservative chlorobutanol, which is used in its formulation.
The product, which is similar to Swiss major Novartis' currently, marketed nasal spray Miacalcin (salmon calcitonin), is intended for use in the treatment of osteoporosis. Nastech said that it will engage in further discussions with the FDA to determine which additional information, if any, the agency requires in order for it to accept the ANDA. The company added that, if it is unsuccessful with its current submission, then it may resubmit the drug under a New Drug Application.
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