FDA grants product registration for ivermectin as ‘anti-nematode drug’
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MANILA, Philippines — The Food and Drug Administration (FDA) granted on Friday a certificate of product registration (CPR) for human use of the locally-manufactured ivermectin.
However, FDA Director General Eric Domingo said that the issued CPR for ivermectin is for its use as an “anti-nematode drug.” Nematodes are parasitic roundworms.
“Lloyd Laboratories applied for a CPR for locally manufactured ivermectin as an anti-nematode drug and it was granted after they submitted data to support quality and stability of the product,” he said in a text message to INQUIRER.net.
Domingo earlier explained that once a CPR is granted, the product can then be commercially available in the market.
Ivermectin has long been used as an antiparasitic drug for animals, but it has not been approved for use as treatment for coronavirus disease. With the grant of the CPR, it can now be used for humans as treatment against nematodes.
The FDA has yet to grant the emergency use authority for ivermectin for coronavirus treatment, although six hospitals have been allowed to use it for patients with COVID-19 under its compassionate special permit.
Aside from Lloyd Laboratories, Domingo earlier said that another company has expressed willingness to file for a CPR of imported-human grade ivermectin before the FDA.
The country is set to conduct clinical trials to determine whether the controversial drug can be used to treat COVID-19 patients. The clinical trials may begin by end of May or early June, according to Jaime Montoya, chief of the Department of Science and Technology-Philippine Council for Health Research and Development.
Montoya said the results of the clinical trials may be known by early 2022.
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