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Manila Bulletin devider Philippines devider National devider Certificate of product registration application for Ivermectin filed before FDA

Certificate of product registration application for Ivermectin filed before FDA

Published Apr 6, 2021 01:41 pm

The Food and Drug Administration on Tuesday, April 6, said it received a certificate of product registration (CPR) application for Ivermectin last week.

Food and Drug Administration (FDA)
(FACEBOOK / FILE PHOTO / MANILA BULLETIN)

“We do have one application for a CPR that was lodged last Wednesday, and we had a meeting with the proponent yesterday and told them the requirements so that they can manufacture it and sell it in a wider sense,” FDA Director General Eric Domingo in an interview over ANC.

Domingo made the statement amid clamor, including some lawmakers, over the possible use of the anti-parasitic drug in the treatment against the coronavirus disease (COVID-19).

“Ivermectin is a drug that is known to be useful as an anti- parasitic. There are both human forms and veterinary forms,” he said.

“In the Philippines, the one’s that are commercially available and registered are veterinary products. So we have asked people to please stay away from the veterinary products,” he added.

The FDA chief said no manufacturer or distributor yet in the country that has a CPR for Ivermectin, but he noted that people can access the drug through pharmacies that have a license for compounding of the drug.

“Ang hindi lang naman pwede sa atin ‘yung mga unauthorized drugs o mga unregistered drugs at tsaka of course hindi pwede mag distribute ng walang prescription (what is prohibited are unauthorized drugs or unregistered drugs, and it is also prohibited to distribute the drug without a prescription),” he said.

In a statement, the Department of Health (DOH) and the FDA said they do not recommend the use of Ivermectin for the treatment of COVID-19.

“Based on the current evidence from randomized controlled trials, the DOH agrees with the COVID-19 Living CPG Reviewers and does not recommend the use of Ivermectin for the treatment of COVID-19,” health authorities said Monday, April 5.

“Moreover, Dr. Rabindra Abeyasinghe, World Health Organization (WHO) Representative to the Philippines, has stated that there is no evidence that supports the use of ivermectin to treat COVID-19, even as a preventive measure,” they added. 

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