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12 Jun 2015

What is the difference between 505(j) application, 505(b)(2) NDA & 505(b)(1) NDA?

505(j) Application

A 505(j) application is an abbreviated new drug application (ANDA) that contains information to show that the proposed product is identical in active ingredient, dosage form, strength, route of administration, labeling, quality, performance characteristics and intended use, among other things, to a previously approved product – the reference listed drug (RLD).

ANDAs do not contain clinical studies as required in NDAs but are required to contain information establishing bioequivalence to the RLD.

A drug product that is the subject of an ANDA is referred to as a generic drug.

505(b)(1) NDA

A 505(b)(1) application is an application that contains full reports of investigations of safety and effectiveness.

The investigations the applicant relied on for approval were conducted by or for the applicant or the applicant has obtained a right of reference or use for the investigations.

Full application – Data predominantly obtained from studies conducted by the sponser.

505(b)(2) NDA
Hybrid between an ANDA [505(j)] and full NDA [505(b)(1)].

A 505(b)(2) application is an application submitted under section 505(b)(1) for which

the investigations the applicant relied on for approval were not conducted by or for the applicant and
the applicant has not obtained a right of reference or use for the investigations (21 U.S.C. 355(b)(2)).
Section 505(b)(2) expressly permits FDA to rely, for approval of an NDA, on data not developed by the applicant – such as published literature or the agency’s finding of safety and/or effectiveness of a previously approved drug product.

 

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