Guidenace-ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved ANDAs

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The FDA just revised its final guidance on amendments and requests for final approval for tentatively approved ANDAs’

This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest date on which the ANDA may lawfully be approved based on patent and/or exclusivity protections.

The previous final version of the guidance was released in September 2020. It details the agency’s policies based on performance goals agreed with the industry under the latest Generic Drug User Fee Amendment (GDUFA III) deal.

It also discusses how the FDA plans to address ANDA sponsor requests for final approval that meet GDUFA III expectations—and clarifies the patent certification process and exclusivities and how they may affect ANDA approval times.

The timing of ANDA approval depends on, among other things, the patent and/or exclusivity protections for the RLD … An ANDA must contain an appropriate patent certification for each patent that claims the RLD or a method of using the RLD for which the ANDA applicant seeks approval in its ANDA and for which the NDA applicant is required to submit information.

The sponsor is required to submit one out of four certifications to the FDA concerning the patent in question. These include:

  • a certification that the patent information has not been filed;
  • a certification stating that the patent has expired;
  • a certification specifying the expiry date of the patent, or
  • a certification claiming that the patent is invalid, unenforceable, or willing to be infringed by the patent-holding manufacturer.

The FDA notes that if a sponsor submits the first two types of certifications, it will not delay their ANDA approval. But if a sponsor submits the third kind of certification, they will have to wait until the patent has expired. Sponsors may also challenge a patent or argue that the patent-holding manufacturer is willing to allow their patent to be infringed by submitting the fourth kind of certification.

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