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doi: 10.1111/myc.70064 17 LandisJ

Mechanism of 505(b)(2) The 505(b)(2) New Drug Application is a hybrid pathway that allows an applicant to rely on the FDAs previous finding of safety and efficacy for an approved drug, while submitting new data for their specific formulation (e.g., a new route of administration or dosage form)

Clinical Cases: Final Considerations

The protocol breaks down as follows

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Interactions Alcohol: Use with caution Alcohol can unpredictably affect blood sugar levels and may worsen common gastrointestinal side effects of Rybelsus, such as nausea