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FDA Offers Advice on When to File and ANDA or 505(b)(2) Application

May 17, 2019

The FDA released final guidance for sponsors on whether to submit an ANDA or a 505(b)(2) new drug application.

An ANDA should not be used if the active ingredient can’t be shown to be the same as that of the reference listed drug (RLD), the agency said, emphasizing that it  has “broad discretion” to determine if an ANDA applicant has provided enough information to establish sameness with the RLD.

But the FDA is willing to be flexible because the regulations outlining the content of an ANDA “do not describe the type or amount of information that an ANDA applicant must submit to demonstrate that the active ingredient in the proposed generic drug product is the same as the active ingredient in the RLD,” the agency said.

The 505(b)(2) NDA pathway is for approval of a drug that’s not new but that’s different in some way from the reference product, so the product “will not necessarily be rated therapeutically equivalent to the listed drug it references,” the guidance states.

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