Regulatory Focus™ > News Articles > 2019 > 4 > Teva, Pfizer Seek Clarity on Tentative ANDA Approval Draft Guidance

Teva, Pfizer Seek Clarity on Tentative ANDA Approval Draft Guidance

Posted 02 April 2019 | By Zachary Brennan 

Teva, Pfizer Seek Clarity on Tentative ANDA Approval Draft Guidance

With the overall goal of reducing the number of complete response letters (CRLs) between tentative approval and final approval for abbreviated new drug applications (ANDAs), Teva Pharmaceuticals and Pfizer are calling on the US Food and Drug Administration (FDA) to elaborate further on some specifics in a draft guidance on tentatively approved ANDAs.

The 12-page draft guidance from last January provides recommendations on the timing and content of amendments to tentatively approved ANDAs to help companies reach final approval on the earliest date by which the ANDA may lawfully be approved.

But the draft also explains how FDA is proposing to prioritize the review of certain ANDA amendments, which Teva explains will “likely lead to delays in approval of tentatively approved ANDAs.”

“Rather than defer amendments until closer to the review date, Teva recommends assigning a review goal date that is consistent with Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), regardless of whether the amendment is made pre or post TA [tentative approval],” the company’s comment says.

Pfizer also seeks additional clarity on deferred amendments, noting: “It is unclear how long the FDA will defer their assessment for, whether the Agency will communicate the deferment and its basis, and what will trigger the eventual review (i.e., request from applicant or prompted by FDA).”

Another section of the draft explains how if an applicant is seeking final approval for an ANDA with a Paragraph III certification, the request for final approval should be submitted “15 months before the earliest lawful approval date.”

But Teva notes: “It is unclear how FDA arrived at 15 months advance notice for final approval of ANDAs with Paragraph III certifications. This timeframe is especially confusing when viewed in the context of FDA’s agreed upon 10-month review timeline for a major amendment. In fact, it directly conflicts with the Agency’s rationale later in the TA Amendments Guidance that allows for 3- month review for a request for final approval submitted as a minor amendment and 10-month review for a request for final approval submitted as a major amendment.”

Similarly, Pfizer calls on FDA to delete this line from the guidance, explaining: “It is unclear why the type of patent certification (Paragraph III) dictates the recommended 15-month submission timing.”

The draft also recommends that an applicant with an ANDA tentatively approved for three or more years before the earliest lawful approval date submit the request for final approval as a major amendment.

But Teva criticizes the idea, saying: “It is unclear why FDA wants to make this a blanket requirement for all ANDAs that have been in TA status for more than three years. If the sponsor has been properly maintaining the ANDA and the Agency has kept up with the sponsor’s submissions to keep the ANDA current, a major amendment will very likely be unnecessary. The only reason such a policy would be necessary is because FDA intends to defer any updates made to a tentatively approved ANDA rather than assist the sponsor in keeping its ANDA up-to-date.”

Teva also takes issue with a case where it believes FDA is treating product-specific bioequivalence guidances as binding. “Teva does not agree that if the only outstanding issue preventing final approval of an ANDA is a change in the product-specific bioequivalence guidance, FDA can issue a CRL,” the comment says.


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