Orphan-drug exclusive approval

(12) Orphan-drug exclusive approval or exclusive approval means that, effective on the date of FDA approval as stated in the approval letter of a marketing application for a sponsor of a designated orphan drug, no approval will be given to a subsequent sponsor of the same drug for the same use or indication for 7 years, except as otherwise provided by law or in this part. A designated drug will receive orphan-drug exclusive approval only if the same drug has not already been approved for the same use or indication.

Source

21 CFR § 316.3

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Scoping language

The definitions and interpretations contained in section 201 of the act apply to those terms when used in this part.

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