FDA Publishes Competitive Generic Therapy Guidance

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The guidance explains the process of applying for competitive generic therapy designation.

On Feb. 15, 2018, FDA published guidance for manufacturers seeking to apply for competitive generic therapy (CGT) designation of a drug product. CGT designation was created as part of the FDA Reauthorization Act of 2017, which allows the agency to give CGT designation and expedite development and review of an abbreviated new drug application (ANDA) as a CGT for health conditions the agency determines lack a sufficient amount of generic treatments.

“Some drugs may not attract a high level of interest from generic drug applicants if there is a limited market for those products and/or if the products are more difficult to develop. Nevertheless, these drugs can play an important role in diagnosing, treating, and preventing various types of diseases or conditions, and incentivizing generic competition for these products can help ensure patients have access to the medicines they need. The provisions associated with CGTs are intended to incentivize effective development, efficient review, and timely market entry of drugs for which there is inadequate generic competition,” the guidance states.

The new guidance outlines the process for applying for CGT designation and includes the actions FDA can take to expedite ANDA reviews. Information on the 180-day exclusivity period for applicants of CGTs is also provided. The guidance discusses the criteria and timing of CGT requests, process for submitting requests, considerations for expedited development, and the specifics of CGT exclusivity.


Source: FDA