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Prior Authorization Approval Criteria ()Generic Name:LevoleucovorinBrand Name:FusilevMedication Class:Antimetabolite antidote FDA Approved Uses: Rescue treatment indicated after high dose therapy
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1 Indications and Usage refers to the specific medical conditions or diseases for which a drug or treatment is approved and intended to be used.
Pharmaceutical companies and manufacturers seeking FDA approval for new drugs must file 1 indications and usage as part of their New Drug Application (NDA) or Biologics License Application (BLA).
To fill out 1 indications and usage, the applicant must provide a comprehensive description of the drug's intended use, the population it is meant to treat, and any specific indications supported by clinical data.
The purpose of 1 indications and usage is to inform healthcare providers about the approved uses of a drug, ensuring safe and effective treatment for patients.
The information reported must include the specific diseases or conditions the drug treats, the patient population, and any limitations or special considerations related to its use.
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