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With
the aim to expedite access to medicines, more than 100 generic drug
applications have been granted approval by FDA.
As per the notification published on 2 September 2021, the United States Food and Drug Administration (US-FDA) has successfully attained the milestone of approval of more than a hundred generic drug applications with a competitive generic therapy (CGT) designation. This accomplishment depicts the success of the CGT program (part of US-FDA Drug Competition Action Plan) that was designed to develop and market generic therapeutics.
Since the commencement of the CGT program in 2017, tremendous interest has been noted, with more than 100 applicants requesting CGT designations. This has offered an opportunity to FDA for approving more than a hundred of these applications in less than 4 years, among the wide-ranging products and therapeutic areas. Furthermore, greater than 80% of the initially approved applicants who had eligibility for CGT exclusivity initiated marketing the drug within seventy-five days following acceptance of US-FDA.
This ensures the development and market availability of efficacious and safe
generics in market areas that previously had little competition. This fosters
generic competition, helps to address the elevated cost of drugs and provides
patients more affordable and expeditious access to medicines.
US-FDA
FDA In Brief: FDA Reaches Milestone in Competitive Generic Therapy Drug Approvals
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