A change that affects every ANDA and 505(b)(2) amendment to an unapproved application

The Office of Generic Drugs started to send out official correspondence saying that an amendment submitted without a verification statement is deficient, because it is not reflecting a new ANDA section of Code of Federal Regulations - 21 CFR 314.96(d). This regulation states as follows:

Patent certification requirements. An amendment to an ANDA is required to contain an appropriate patent certification or statement described in Sec. 314.94(a)(12) or a recertification for a previously submitted paragraph IV certification if approval is sought for any of the following types of amendments:

a) To add a new indication or other condition of use;

b) To add a new strength;

c) To make other than minor changes in product formulation; or

d) To change the physical form or crystalline structure of the active ingredient.

If the amendment to the ANDA does not contain a patent certification or statement, the applicant must verify that the proposed change described in the amendment is not one of the types of amendments described above.

FDA recommends to reference a patent certification or section viii statement, or recertification in the cover letter of an amendment to an unapproved ANDA and include such in module 1.3 of the unapproved ANDA. If applicant intends to provide a verification statement, this should be included in the cover letter of an amendment to an unapproved ANDA.

Asphalion specializes in publishing and submission of ANDA and any other application types to FDA. Do not hesitate to contact us at fda@asphalion.com for further information about patent certification requirements or assistance for your FDA projects.