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Failure to submit an annual report for studies or clinical trials required under 505 o on the date required will be considered a violation of FDCA section 505 o 3 E ii and could result in enforcement action. UNDER SECTION 506B We remind you of your postmarketing commitment 2779-2 An in vitro study to evaluate the time-dependent/mechanism-based inhibition potential of naloxegol on the hepatic CYP2C8 enzyme. FDA will consider the submission of your annual report under section 506B and 21 CFR...
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Generic name naloxegol is pegylated naloxone
The pharmaceutical company manufacturing or distributing the medication is required to file generic name naloxegol.
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The purpose of generic name naloxegol is to provide a standardized name for the medication that can be used in medical and regulatory documents.
The information that must be reported on generic name naloxegol includes the chemical composition, indication, dosage, and potential side effects of the medication.
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