The FDA granted a certificate of product registration for ivermectin as an “anti-nematode drug”.
The Food and Drug Administration (FDA) on Friday granted a certificate of product registration (CPR) for human use of the locally-manufactured ivermectin as an “anti-nematode drug”.
However, FDA Director-General Eric Domingo said that the issued certificate of product registration (CPR) for ivermectin was for its use as an “anti-nematode drug” and not as a treatment for COVID-19.
In a text message to Inquirer, Domingo said that Lloyd Laboratories applied for a certificate of product registration for locally-manufactured Ivermectin as an “anti-nematode drug” and it was granted after they had submitted data to support stability and quality of the said product.
Earlier, Domingo explained that the product can then be commercially available in the market once a certificate of product registration was granted.
Ivermectin has long been used as an “anti-parasitic drug” for animals, but it has not been approved for human use as treatment for COVID-19. With the grant of the certificate of product registration, it can then be used for humans as a treatment against nematodes.
The Food and Drug Administration has yet to grant the emergency use authorization (EUA) for Ivermectin for COVID-19 treatment, although 6 hospitals had been allowed to use the said drug for COVID-positive patients under its “compassionate special permit (CSP)”.
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Aside from Lloyd Laboratories, Domingo earlier said that another firm had expressed willingness to file for a certificate of product registration of imported-human grade ivermectin before the Food and Drug Administration.
The Philippines was set to conduct human clinical trials in order to determine whether the controversial drug can be used to treat COVID-positive patients.
Jaime Montoya, chief of the Department of Science and Technology-Philippine Council for Health Research and Development (DOST-PCHRD), said that the human clinical trials may start by end of May or early June.
Montoya also said that the results of the human clinical trials may be known by early 2022.
Nematodes were “parasitic roundworms”.
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