Pharmacy2Home/LandiCom Holding LTD

Selected passages from the FDA letter

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

Passage 1

While there are FDA-approved versions of chloroquine on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Chloroquine (CoronaVirus Covid-19)” offered by www.pharmacy2home.com.

Passage 2

While there are FDA-approved versions of oseltamivir on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Antiflu 75 mg (Oseltamivir)” manufactured by Cipla and offered by www.pharmacy2home.com.

Passage 3

Furthermore, while there are also FDA-approved versions of ribavirin and lopinavir + ritonavir on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “CoronaVirus pack (Ritonavir 50mg + Lopinavir 200mg, Ribavirin 200mg, Oseltamivir 75mg)” offered by www.pharmacy2home.com.

Passage 4

While there are FDA-approved versions of ivermectin on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Ivermectin 12mg ” offered by www.pharmacy2home.com.

Passage 5

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 for their intended uses. Consequently, the labeling for these drugs fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act.