Nastech's calcitonin-salmon nasal spray denied by FDA

By Elaine Rigoli

Tampa, Fla., July 13 - Nastech Pharmaceutical Co. Inc. said Thursday that it has received written notification from the Food and Drug Administration denying the company's abbreviated New Drug Application for intranasal calcitonin-salmon.

Nastech said the FDA expressed a concern relating to the potential for immunogenicity that might result from a possible interaction between calcitonin-salmon and chlorobutanol, the preservative in the formulation.

The company said other existing marketed nasal spray products contain chlorobutanol as the preservative.

Nastech said it will engage in further discussions with the FDA to determine what additional data to submit to the FDA. If Nastech is not successful at keeping this application as an abbreviated NDA, the company said it may pursue a 505(b)(2) New Drug Application.

Nastech said the formulation of calcitonin-salmon nasal spray was specifically developed to be similar to Novartis' currently marketed calcitonin-salmon nasal spray, Miacalcin, in order to submit the application as an abbreviated NDA.

Nastech is a pharmaceutical company located in Bothell, Wash.

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