This guidance provides recommendations to assist applicants in incorporating information into proposed human prescription drug labeling when:
This practice is referred to as dose banding.
This guidance applies to proposed labeling in a new drug application (NDA) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); a biologics license application (BLA) submitted under section 351(a) of the Public Health Service Act (PHS Act); or a supplement to one of these approved applications.
This guidance does not apply to abbreviated new drug applications (ANDAs), which are generally required to have the same labeling as the reference listed drug. This guidance also does not apply to 351(k) BLAs; the labeling of biosimilar and interchangeable products generally incorporates relevant data and information from the reference product labeling with certain modifications.
BACKGROUND AND SCOPE
Having multiple different strengths of a drug product available in ready-to-use containers from which the entire drug content of the container(s) is administered to the patient may simplify the preparation and administration of a drug compared to preparing and administering an exact weight- or BSA-based dose to the patient. The availability of a drug product in a range of different strengths in ready-to-use containers (for example, pre-mixed infusion bags) that could be administered in their entirety also may reduce significant drug waste from single-dose vials used for exact weight- or BSA-based dosing and would eliminate the need to calculate and extract partial doses from vials.
For example, consider a drug product that is available in 1000 milligram (mg) single-dose vials (100 mg/milliliter (mL)) when the calculated dose for the patient is 1250 mg. Administering this exact dose would necessitate use of two vials, with the residual 750 mg in the second vial being discarded. The use of a pre-mixed, ready-to-use infusion bag that delivers 1250 mg of the drug simplifies the preparation and administration steps.
Administering the entire drug content of a ready-to-use container, however, may result in a patient receiving a dose that is very close to but not exactly the same as the dose calculated based on weight or BSA. Therefore, labeling must provide clear instructions for health care practitioners on preparation and administration of the drug product, which should include information on how to determine which strength(s) of the ready-to-use containers the patient should receive based on the patient’s weight or BSA. In some instances, dosing with ready-to use containers may entail administration of a single ready-to-use container (for example, one infusion bag). In other situations, a patient may need two (or more) ready-to-use containers (for example, using two infusion bags of different strengths to provide the total dose to be administered) to receive the recommended dose.
The recommendations and examples in this guidance apply when an applicant (1) proposes to develop ready-to-use containers with a range of different strengths and (2) seeks to incorporate dose banding information into the prescribing information of the proposed drug product based on dosing information of a previously approved drug product that is based on weight or BSA.
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