Generic drug approvals continued to fall in 2021

Regulatory NewsRegulatory News | 16 February 2022 |  By 

The US Food and Drug Administration (FDA) approved or tentatively approved 776 Abbreviated New Drug Applications (ANDAs) for generic drugs in 2021, continuing a steady decline in generic approvals in recent years.
In calendar year 2020, FDA approved or tentatively approved 948 ANDAs for generic drugs, which was down from 1,014 in 2019. The latest figures are part of the FDA’s Office of Generic Drugs (OGD) 2021 Annual Report.
But the agency approved 93 “first generics” in 2021, up from 72 in 2020. FDA prioritizes review of first generic drugs, which provide access to therapies where no competition previously existed. Some of the notable first generics approved in 2021 include:
  • Linaclotide capsules to treat irritable bowel syndrome with constipation
  • Apremilast tablets to treat moderate to severe plaque psoriasis
  • Hydrocodone bitartrate extended-release capsules to treat severe pain
  • Ibrutinib capsules to treat mantle cell lymphoma
  • Enzalutamide capsules to treat prostate cancer
  • Lenalidomide capsules to treat multiple myeloma, anemia, and certain lymphomas
  • Tofacitinib tablets to treat certain types of arthritis and ulcerative colitis
  • Difluprednate ophthalmic emulsion to treat inflammation and pain associated with ocular surgery and treatment of endogenous anterior uveitis
  • Varenicline tablets for smoking cessation
  • Linagliptin tablets to treat Type 2 diabetes mellitus
  • Dasatinib tablets to treat chronic myeloid leukemia
“In 2021, even with the unique challenges caused by the ongoing pandemic, OGD continued to innovate and conduct scientific research to keep the FDA generic drug program moving forward,” wrote OGD Director Sally Choe.
The OGD also reported on progress made with the Competitive Generic Therapy (CGT) pathway, which provides 180 days of marketing exclusivity to approved products with “inadequate generic competition.” The program was first established by Congress in 2017 and FDA issued final guidance on the program’s incentives and the process to request designation in March 2020 (RELATED: FDA Finalizes Guidance on Competitive Generic Therapies, Regulatory Focus 13 March 2020). Overall, OGD has approved 119 generic drugs through the CGT pathway, with 52 approvals in 2021.
The COVID-19 pandemic continued to be a focus for FDA in 2021. OGD approved more than 75 ANDAs for COVID-19-related supportive therapies, including generic approvals for dexamethasone injection, succinylcholine chloride injection, propofol emulsion injection, and dexmedetomidine hydrochloride injection.
OGD funded about $20 million in generic drug science and research programs in 2021. Among the research outcomes the agency highlighted were in vitro and in vivo studies to provide insights into the role of excipients in abuse-deterrent opioid drug products, research into artificial intelligence methods to improve data analytics, and research into the differences in anatomy and physiology between animals and humans to aid the extrapolation of animal data to humans. The OGD research agenda also focused on facilitating development of complex generic drugs through the development of an efficient in vitro bioequivalence approach, which led to the approval of two generic ophthalmologic drugs.
On a global level, OGD continued its collaboration with European regulators and launched a pilot program to provide parallel scientific advice to developers of complex generic drug products in September 2021. The Parallel Scientific Advice program with the European Medicines Agency allows assessors to exchange their views on scientific issues with applicants during the development phase of complex generic drug products. Earlier in 2021, OGD launched the Global Generic Drug Cluster, a global forum for regulatory agencies to increase scientific alignment related to generic drug development (RELATED: FDA launches global Generic Drug Cluster, Regulatory Focus 14 June 2021).
OGD 2021 Annual Report  


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