Novo Nordisk has disclosed that the FDA issued a refusal-to-file letter regarding the company's marketing application seeking to expand approval of Ozempic (semaglutide) to include a 2-mg dose for the treatment of type 2 diabetes.
Per the company’s press release:
“In the letter, FDA has requested additional information including data relating to a proposed new manufacturing site. While additional information needs to be included in the resubmission, Novo Nordisk believes the already completed clinical trial programme will be sufficient for approval of the label expansion application.”
Now we don’t think this will kill . . .
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