FDA approves first drug via Competitive Generic Therapy pathway Posted 12/10/2018

The US Food and Drug Administration (FDA) announced on 8 August 2018 that it had approved its first drugs under the Competitive Generic Therapy (CGT) designation. The agency granted approval to several strengths of Canada-based Apotex’s potassium chloride oral solution.

Potassium chloride is an oral treatment that is indicated for treating and preventing hypokalaemia (low potassium blood levels) in patients taking diuretics and when dietary management with potassium-rich foods is insufficient or the diuretic dose cannot be reduced.

According to FDA Commissioner Scott Gottlieb ‘this approval demonstrates that the CGT pathway is efficient and open for business’. He went on to point out that this generic ‘was also approved in its first cycle of review’ and described the pathway as ‘a key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition’, so patients have access to affordable treatments.

The CGT pathway was introduced in 2017 under the Reauthorization Act of 2017 (FDARA). It gives FDA the authority to designate a drug as a Competitive Generic Therapy if there is inadequate generics competition for that drug, meaning there is not more than one approved drug in the active section of the Orange Book. Applicants for drugs that receive a CGT designation may receive review enhancements and expedited review of their abbreviated new drug applications (ANDAs). Applicants for drugs that receive a CGT designation are also eligible for a 180-day period of marketing exclusivity if they are the first approved applicant for that CGT and meet certain other condition.

FDA has introduced a number of different measures to try and increase generics competition and they appear to be working. The agency is on track to top its fiscal year 2017 record for generics approvals despite receiving fewer ANDA submissions.

The agency approved 96 generics in the period between 18 June and 18 July 2018, giving a total of 666 generics approved so far in the fiscal year and granting tentative approval for 162 generics. With just two months left in the fiscal year and an average of 67 approvals a month, the agency looks set to break the 2017 record of 763 generic drug approvals.

Related article
FDA to speed up review of priority generics

References
1.  GaBI Online - Generics and Biosimilars Initiative. FDA forms working group to increase generics competition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 12]. Available from: www.gabionline.net/Generics/General/FDA-forms-working-group-to-increase-generics-competition
2.  GaBI Online - Generics and Biosimilars Initiative. FDA to boost generics and change drug rebates to lower prices [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 12]. Available from: www.gabionline.net/Generics/General/FDA-to-boost-generics-and-change-drug-rebates-to-lower-prices

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Source: US FDA

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