FDA in record year for generic approvals

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Fotogestoeber)
(Image: Getty/Fotogestoeber)

Related tags: US FDA, Generics, Ned Sharpless

US FDA breaks the previous record, set in 2018, on the number of generics approvals with a total of 1,171 generic drugs approved.

FDA statistics on generics:

2019 approvals:​ 1,171

-          935 full approvals

-          236 tentative approvals

-          125 'first generics'

2018 approvals: ​971

Total savings made from generics that year:​ $293bn

Generics % of prescription drug purchases:​ 90%

In 2018, the US Food and Drug Administration (FDA) approved 971, which was itself a record – as the agency prioritized increasing competition​ on the generics market.

The news was announced in a statement by acting FDA commissioner, Ned Sharpless, who highlighted that of the approvals made, 125 were related to generics that entered the market for treatments that had previously had no competition.

Of these, ‘first generic treatments’ a emergency opioid overdose treatments​, of particular importance given the US’ ongoing opioid crisis​, as well as approvals for various treatments for breast cancer, seizures, and depression.

The agency also noted that it had improved the number of complex generic drugs, an area the record of which the FDA has also been looking to improve.

Regarding future steps, Sharpless stated, “In the coming months, we plan to publish additional guidances and take other important policy steps to assist generic drug applicants, including planning additional conferences on generic drug development to further engage with stakeholders and generic drug developers.”

He also reiterated why generic approvals are important for the US healthcare system, citing that approximately 90% of prescription medicines are generics and that total savings for 2018, afforded by generics, was $293bn (€263bn).

In further detail provided on the financial year, it was revealed that the agency had issued 2,310 complete response letters (CRLs), which was a drop of 15% on the previous year.

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