- Novo Nordisk A/S NVO has resubmitted a label expansion application to FDA for Ozempic (semaglutide) to introduce a new dose of 2.0 mg.
- Semaglutide is a glucagon-like peptide-1 (GLP-1) analog.
- The Type 2 diabetes injection is currently approved at 0.5-mg and 1-mg doses given once a week.
- The resubmission follows the Refusal to File letter received by the FDA in March.
- The agency was looking for additional information about a proposed new manufacturing site. The company said that the already-completed clinical trial program would be sufficient to approve the label expansion application.
- The standard review time by the FDA is ten months.
- Price Action: NVO shares are up 0.34% at $79.09 during the market session on the last check Friday.
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