definiens: means, with respect to a product, a use to which such product is intended to be put for the treatment, prevention or cure of a distinct recognized disease or condition, or of a manifestation of a recognized disease or condition, which, if approved in the U.S., would be reflected i n the section of labeling pursuant to 21 C.F.R. § 201.57(c)(2 ) or, to the extent applicable, any comparable labeling section outside the U.S., subject to the following : ( a ) [ † ] are not different Indications ; ( b ) [ † ] are not different Indications, even if [ † ] ; ( c ) [ † ] are not different Indications ( e.g., [ † ] ) ; ( d ) [ † ] are not different Indications ; ( e ) [ † ] are not different Indications ( e.g., [ † ] ) ; and ( f ) [ † ] are not different Indications