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# Changes Sought in Competitive Generics Guidance
- URL: https://www.fdaweb.com/changes-sought-in-competitive-generics-guidance/
- Published: 2019-04-23T12:00:00.000Z
- Updated: 2026-09-15T01:22:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143935

The Association for Accessible Medicines says it supports the underlying goals of an FDA draft guidance on competitive generic therapies (CGT), and believes the agency could clarify how CGT designations and exclusivity will be determined and communicated to applicants. The association’s comment [letter](https://www.regulations.gov/document?D=FDA-2019-D-0065-0008&ref=fdaweb.com) says **(1)** FDA should provide greater transparency around when a drug is eligible for CGT designation; **(2)** greater clarity around certain additional scenarios consistent with the goals of the CGT provisions, where a drug may be eligible for CGT designation and exclusivity; and **(3)** FDA should revise the draft to include further details about the timing of the steps on the CGT designation and exclusivity process.

In its [comment](https://www.regulations.gov/document?D=FDA-2019-D-0065-0009&ref=fdaweb.com), Teva says it is pleased overall with the draft guidance and “appreciates the help it provides to explain the nuances of the statutory construction of both the application prioritization process and related exclusivity.” The company suggests that FDA bring a spirit of transparency to the CGT process by publicizing those products for which CGT designation has been granted for approved ANDAs, as well as timely publication of when CGT exclusivity is awarded. “Since multiple applicants may achieve CGT designation for the same product,” it says, “it is helpful to know when the first approved ANDA is granted 180-day exclusivity.”

Pfizer says the draft guidance as written can be difficult to follow at times and certain recommendations and interpretations can seem inconsistent with other information in the draft. It [recommends](https://www.regulations.gov/document?D=FDA-2019-D-0065-0006&ref=fdaweb.com) that the agency streamline its discussion throughout the draft to avoid confusion from stakeholders regarding CGT designations and exclusivity. Pfizer says FDA also should consider including flow charts to graphically represent the CGT designation and exclusivity decision processes.