FDA Publishes Guidance for Making Generic Versions of Chloroquine, Hydroxychloroquine

April 15, 2020 Updated: April 15, 2020

Expecting increased demand for chloroquine phosphate and hydroxychloroquine sulfate, the Food and Drug Administration has published guidance for making generic versions of the existing drugs, which are being tested in COVID-19 patients across the United States.

While clinical trials studying the safety and effectiveness of the drugs are ongoing, doctors in multiple states are prescribing them as a treatment for the new disease—which is caused by the CCP (Chinese Communist Party) virus, commonly known as the novel coronavirus—or as a prophylactic.

Shortages of the drugs—typically used to treat a number of ailments, including lupus, rheumatoid arthritis, and malaria—have already been reported in some areas.

The guidance to drug makers from the Food and Drug Administration’s Center for Drug Evaluation and Research and Office of Medical Products and Tobacco was made “in anticipation of increased demand” for the tablets, according to the FDA.

Chloroquine phosphate has no known or suspected “bioequivalence problems,” according to the guidance, and is rated as “AA” in a book issued by the administration. No in vivo studies are thus necessary.

The guidance for hydroxychloroquine sulfate includes advice about a biowaiver-option.

“A waiver request of in vivo testing for this product may be considered provided that the appropriate documentation regarding high solubility, very rapid dissolution, and the test product formulation is qualitatively the same and quantitatively very similar as detailed in the ‘Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence for Immediate Release Solid Oral Dosage Forms Based on the Biopharmaceutics Classification System,'” the guidance states.

hydroxychloroquine bottle
A pharmacist shows a bottle of the drug hydroxychloroquine in Oakland, Calif., on April 6, 2020. (Ben Margot/AP Photo)

“A decision regarding the acceptability of the waiver request will be made upon assessing the data submitted in the application.”

Along with the guidance, the FDA “is prioritizing review of any newly submitted Abbreviated New Drug Applications for these drugs,” Dr. Stephen Hahn, the agency’s commissioner, said in a statement this week.

The rush to obtain chloroquine or hydroxychloroquine tablets after some patients and doctors began attesting to their effectiveness against COVID-19 led to warnings about shortages, particularly among doctors and groups involved in treating patients who relied on the medicine before the pandemic started.

The Maryland Board of Physicians stated in an alert that it received reports of “inappropriate activity” related to the medications, including allegations that prescribers “are inappropriately issuing prescriptions and refills for those medications and hoarding or stockpiling the medications for themselves, family members, friends, and coworkers without any apparent medical indication, or in anticipation of COVID-19 related illness.”

Shortages of the drugs could be linked to this apparent hoarding, the board stated.

Several states, including Nevada and New York, have put some restrictions on the use of the anti-malaria drugs for COVID-19 because of concerns there wouldn’t be enough of them left for patients with a more urgent need for it.

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