Reply To: Letter to the FDA about dosage and repurposing trials

[TheRealRestoreInc.]

FDA’s Reply to my letter shows how to apply for veterinary ivermectin repurposing for Covid-19, but not encouraging.

Dear [name withheld],

Thank you for writing to the Division of Drug Information in the FDA’s Center for Drug Evaluation and Research (CDER).

We appreciate that you chose to share your concerns and suggestions with us.

While there are approved uses for ivermectin in people and animals, it is not approved for the prevention or treatment of COVID-19. You should not take any medicine to treat or prevent COVID-19 unless it has been prescribed to you by your health care provider and acquired from a legitimate source.

FDA has issued the following public statements and resources related to Ivermectin and COVID-19:

FDA Letter to Stakeholders: Do Not Use Ivermectin Intended for Animals as Treatment for COVID-19 in Humans

FAQ: COVID-19 and Ivermectin Intended for Animals

A recently released research article described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. These types of laboratory studies are commonly used at an early stage of drug development. Additional testing is needed to determine whether ivermectin might be appropriate to prevent or treat coronavirus or COVID-19.

Please understand that, in general, FDA does not conduct clinical studies. In order for a human drug to be marketed in the United States for a certain use (such as ivermectin for the treatment of COVID-19), an organization or company (also called the sponsor) must submit a New Drug Application to the FDA demonstrating the drug is both safe and effective for its intended use. A new use for a previously approved drug may also require a New Drug Application. Through review of the New Drug Application and data submitted by the sponsor, the FDA determines whether the evidence is sufficient to demonstrate safety and efficacy of the drug for the intended use. To get a general idea of what information is required to prove safety and efficacy please see The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective

FDA remains actively engaged with partners across the U.S. government, academia and regulated industry to expedite the development and availability of critical medical products to prevent and treat this novel virus – this work includes collecting data in a variety of ways to both evaluate the safety and efficacy of potential therapies and facilitate emergency access for patients, as appropriate.

For the latest updates from FDA, visit: Coronavirus Disease 2019 (COVID-19)

Best Regards,

KC

Pharmacist

Division of Drug Information

Center for Drug Evaluation and Research

Tel: 855-543-DRUG (855-543-3784)

This communication is consistent with 21 CFR 10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.