OGD sees higher approvals in 2022

Regulatory NewsRegulatory News | 02 March 2023 |  By 

The number of US generic drug approvals rebounded in 2022 after a drop in 2021. In calendar year 2022, the US Food and Drug Administration (FDA) approved or tentatively approved 917 abbreviated new drug applications (ANDAs).
In 2021, FDA approved or tentatively approved 776 ANDAs for generic drugs, down from 948 in 2020 and 1,014 in 2019. The latest figures are part of FDA’s Office of Generic Drugs (OGD) 2022 Annual Report. (RELATED: Generic drug approvals continued to fall in 2021, Regulatory Focus 16 February 2022).
The 2022 ANDAs include 106 “first generics” for drugs that previously had not had generic competition. In the report, FDA highlighted the first generic approval of cyclosporine ophthalmic emulsion, 0.05%, which references the dry eye treatment Restasis.
“The FDA assessment team extensively collaborated to resolve the scientific challenges underlying the approval of this complex generic ophthalmic drug product,” OGD wrote in the report. “This approval was, in large part, possible because FDA has been conducting research to address complex issues related to the assessment of a proposed generic product to Restasis as part of OGD’s [Generic Drug User Fee Amendments] Science and Research Program since 2012.”
Other notable first generics approved in 2022 include:
  • Sofosbuvir tablets for hepatitis C virus infection
  • Brimonidine Tartrate ophthalmic solution for elevated intraocular pressure
  • Dapagliflozin tablets for glycemic control
  • Apomorphine hydrochloride injection for Parkinson’s disease
  • Lacosamide tablets for partial-onset seizures
  • Bortezomib for injection to treat multiple myeloma and mantle cell lymphoma
  • Pemetrexed for injection to treat non-squamous, non-small cell lung cancer and mesothelioma
  • Empagliflozin tablets for type 2 diabetes mellitus
OGD also continued to implement FDA’s Drug Competition Action Plan (DCAP) in 2022. That implementation included publication of draft guidances and product-specific guidances related to physicochemical and structural characterization tests, in vitro release test (IVRT) studies, and in vitro permeation test (IVPT) studies for topical generic drug products.
The report also touted OGD’s research efforts, including the funding of $20 million in science and research projects and 77 ongoing external research collaborations. One research highlight was the development of physiologically based pharmacokinetic (PBPK) models for morphine sulfate and naltrexone hydrochloride and their use in creating abuse-deterrent opioid drug products.
“The validated PBPK models were used to investigate the effect of different drug particle size distributions (PSDs) between 100 and 500 μm on in vivo systemic PK parameters, and the models predicted that the PK would be dependent on the PSD of morphine sulfate, but not that of naltrexone hydrochloride. This research illustrated the value of in silico modeling tools during generic drug development, to inform the design of [abuse-deterrent formulations] of opioid drug products,” OGD wrote.
OGD 2022 Annual Report


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