ivermectin

FDA OKs registration of ivermectin for human anti-parasitic treatment

Bonz Magsambol
FDA OKs registration of ivermectin for human anti-parasitic treatment

Clamart, France - April, 2, 2021: Box of Ivermectin (French packaging), an antiparasitic drug and also a potential treatment for Covid-19 disease

Shutterstock photo

However, as experimental treatment for COVID-19, oral ivermectin is allowed by the FDA only on two instances: if the medical facility dispensing the drug secured a compassionate special permit, or if a doctor has prescribed it and the drug is compounded by a pharmacist according to the prescription

The Philippines’ Food and Drug Administration (FDA) has issued a certificate of product registration (CPR) to a local company to register ivermectin for human anti-parasitic treatment.

“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,” FDA chief Eric Domingo told Rappler in a text message on Friday, May 7.

Nematodes are parasitic roundworms that could infect humans.

A CPR is a certificate issued by the FDA that would allow a product to be commercially available in the market. Domingo, however, said that a medical prescription is still needed when buying the drug.

Llyod Laboratories is a drug manufacturer based in Quezon City. According to its website, the company “undertakes manufacturing of tablets, capsules, liquid orals, ointments, pellets, dry powder inhalers and nasal spray formulations.”

While ivermectin for humans are administered in other countries, in the Philippines the only oral and intravenous ivermectin that have FDA approval are the ones for animals. The ones permitted for humans are in the form of ointments.

However, as experimental treatment for COVID-19, oral ivermectin is allowed by the FDA only on two instances: if the medical facility dispensing the drug secured a compassionate special permit, or if a doctor has prescribed it and the drug is compounded by a pharmacist according to the prescription.

There is an ongoing public debate over the use of ivermectin to treat COVID-19 – with some doctors recommending it and patients sharing how it had been beneficial to them, while other medical experts issued a stern warning against its unproven use in treating the deadly disease.

Amid the debates, President Rodrigo Duterte ordered the Department of Science and Technology (DOST) and DOH to study the use of ivermectin as a possible treatment against COVID-19. He gave the order a week after the DOST itself said there was no need for local studies as there were ongoing trials abroad whose results can inform decisions in the Philippines. – Rappler.com

Bonz Magsambol

Bonz Magsambol is a multimedia reporter for Rappler, covering health, education, and social welfare. He first joined Rappler as a social media producer in 2016.