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
DOI https://doi.org/10.22270/ijdra.v9i2.463

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
4. Federal Food and Drug Reauthorization Act, Section 803 [Internet]. Federal Food and Drug Reauthorization Act; 2017 Aug 18 [cited 2021 Apr 01]. Available from: https://www.congress.gov/115/plaws/publ52/PLAW-115publ52.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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Patel H, Dhulia I, Dobariya U, Pardeshi N, Katariya Y. Regulatory aspects for competitive Generic Therapies in USA. Int J Drug Reg Affairs [Internet]. 2021Jun.15 [cited 2024Sep.11];9(2):16-9. Available from: https://ijdra.com/index.php/journal/article/view/463
Issue
Vol 9 No 2 (2021): VOLUME 9, ISSUE 2, 2021
Section
Review
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