Health Law Daily Agency provides recommendations on bioequivalence studies for antimalarials
Tuesday, April 14, 2020

Agency provides recommendations on bioequivalence studies for antimalarials

By Patricia K. Ruiz, J.D.

Two final guidances addressing antimalarials for COVID-19 treatment.

The FDA released two final guidances for industry providing product-specific recommendations on the design of bioequivalence studies to support an abbreviated new drug application. One of the documents will be implemented without prior public comment because it is not feasible or appropriate in light of the novel coronavirus disease 2019 (COVID-19) public health emergency. The two drugs are antimalarials that have shown some efficacy in treating COVID-19 (Notice, 85 FR 20696, April 14, 2020).

Guidance on hydroxychloroquine sulfate. A 2010 guidance for industry entitled "Bioequivalence Recommendations for Specific Products" explained the process that would be used to make product-specific guidances available to the public. The FDA adopted the process as a means to develop and disseminate product-specific guidances and provide meaningful opportunity for the public to consider and comment on such guidances. "Guidance on Hydroxychloroquine Sulfate" was developed using the process described in the 2010 guidance. Hydroxychloroquine sulfate is an antimalarial medicine approved in the U.S. for either prevention or treatment of certain types of malaria, lupus erythematosus, and rheumatoid arthritis. It may benefit certain patients hospitalized with COVID-19 for whom a clinical trial is not available or participation is not feasible.

Guidance on chloroquine phosphate. The document "Guidance on Chloroquine Phosphate" will be implemented without prior public comment because of the COVID-19 public health emergency. While the FDA will implement the document immediately, it remains subject to comment in accordance with the FDA’s good guidance practices, and the FDA will revise the guidance as warranted and appropriate after reviewing any public comment received. Chloroquine phosphate is an older drug used to treat malaria.

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