Regulatory aspects for competitive Generic Therapies in USA

  • Himani Patel Isazi Pharma and Techno Consultancy Private Limited
  • Iva Dhulia
  • Umesh Dobariya
  • Nidhi Pardeshi
  • Yogesh Katariya

Abstract

The FDA Reauthorization Act (FDARA) of 2017 lets generic companies ask for expedited review and 180-day exclusivity for a Competitive Generic Therapies (CGT)-designated product. (1)


FDA guidance for industry on Competitive Generic Therapies (CGT) provides keen information for generic drug manufacturers who want to develop a drug with inadequate generic competition. This guideline is specially published for generic players. If you are a generic manufacturer or sponsor, this will



  • Explain the process and criteria to request and designate a drug as a CGT.

  • Information on the actions FDA may take to expedite the development and review of ANDAs designated as CGT.

  • Implementation of 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs. (1)

Keywords: FDA Reauthorization Act (FDARA), FD&C Act, ANDA, Competitive Generic Therapy, Inadequate Generic Competition

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References

1. Competitive Generic Therapies [Internet]. USFDA; 2020 [cited 2021 Apr 07]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/competitive-generic-therapies
2. Competitive Generic Therapies, Guidance for Industry [Internet]. USFDA; 2020 [cited 2021 Apr 01]. Available from: https://www.fda.gov/media/136063/download
3. Federal Food, Drug, And Cosmetic Act, Section 506H(e)(2)(A) [Internet]. Federal Food, Drug, And Cosmetic Act; [updated 2021 Jan 05; cited 2021 Apr 02]. Available from: https://www.govinfo.gov/content/pkg/COMPS-973/pdf/COMPS-973.pdf
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12. M SK, Katamreddy JD, P JR. A review on ANDA submission requirements for Generic drugs: “Paragraph IV certification” as per FDA CDER guidelines. Int J Drug Reg Affairs [Internet]. 2018 Sep 15 [cited 2021 Jun 15];6(3):5-12. Available from: http://ijdra.com/index.php/journal/article/view/260
13. Shah S, Badjatya JK. Preliminary requirement for filing application in US. Int J Drug Reg Affairs [Internet]. 2018 Dec 20 [cited 2021 Jun 15];6(4):1-. Available from: http://ijdra.com/index.php/journal/article/view/276
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How to Cite
Patel, H., I. Dhulia, U. Dobariya, N. Pardeshi, and Y. Katariya. “Regulatory Aspects for Competitive Generic Therapies in USA”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 2, June 2021, pp. 16-19, doi:10.22270/ijdra.v9i2.463.