I believe it can be submitted under the 505(b)(2) FDA pathway.
"The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”) drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant.""
So in effect, they can submit a new drug application (NDA) and they can rely on data that has been developed by others. E.g., when this drug was first approved as an oral agent, the same data may be used in the submission of the drug now being used for nasal application.
Ann: Suspension from Quotation, page-22
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