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Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your website states, “Molnupiravir is an oral medication, that is authorized by the FDA to treat Covid-19. Molnupiravir is active against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Early treatment with the drug reduces the risk of hospitalization or death in at-risk patients that have or have not been vaccinated.”

Passage 2

Your website states, “CellCept, brand name product by Roche is used to prevent your body from rejecting a kidney, liver, or heart transplant. CellCept (mycophenolate mofetil) lowers your body’s immune system.”

Passage 3

Your website states, “Prograf (Tacrolimus) is used to lower the body’s immune system to help fight infections. Tacrolimus is most widely used on organ transplant recipients to have a better chance of the organ to be accepted in their body.”

Passage 4

Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely

Passage 5

These drugs are also misbranded under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)] because they fail to bear “adequate warnings against use…where [their] use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application....”