covered drug
(1) The term “covered drug” means a drug approved under section 355(c) of this title — (A) for which there are no unexpired patents included in the list under section 355(j)(7) of this title and no unexpired period of exclusivity; (B) for which the approval of the application has been withdrawn for reasons other than safety or effectiveness; and (C) for which— (i) (I) there is new scientific evidence available pertaining to new or existing conditions of use that is not reflected in the approved labeling; (II) the approved labeling does not reflect current legal and regulatory requirements for content or format; or (III) there is a relevant accepted use in clinical practice that is not reflected in the approved labeling; and (ii) updating the approved labeling would benefit the public health.