Local firm applies for emergency use authorization for antiviral drug Molnupiravir | ABS-CBN
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Local firm applies for emergency use authorization for antiviral drug Molnupiravir
Local firm applies for emergency use authorization for antiviral drug Molnupiravir
Job Manahan,
ABS-CBN News
Published Nov 18, 2021 01:44 PM PHT
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Updated Nov 19, 2021 03:52 PM PHT

MANILA (UPDATE)— Local firm Faberco Life Sciences Inc. has applied for emergency use authorization (EUA) in the Philippines for Merck's antiviral medicine Molnupiravir, an investigational COVID-19 drug, the country's drug regulator chief has said.
MANILA (UPDATE)— Local firm Faberco Life Sciences Inc. has applied for emergency use authorization (EUA) in the Philippines for Merck's antiviral medicine Molnupiravir, an investigational COVID-19 drug, the country's drug regulator chief has said.
Food and Drug Administration (FDA) Director-General Eric Domingo said the Philippine-based firm applied last week and it is being evaluated.
Food and Drug Administration (FDA) Director-General Eric Domingo said the Philippine-based firm applied last week and it is being evaluated.
"Last week nag-apply na rin sila ng emergency use authorization and this is now in evaluation. May mga questions lang 'yung mga experts natin sa applicant na needs to be answered," Domingo told ANC on Thursday.
"Last week nag-apply na rin sila ng emergency use authorization and this is now in evaluation. May mga questions lang 'yung mga experts natin sa applicant na needs to be answered," Domingo told ANC on Thursday.
(Last week they applied for EUA and this is now in evaluation. Our experts just have questions to the applicant.)
(Last week they applied for EUA and this is now in evaluation. Our experts just have questions to the applicant.)
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"Last week, nag-apply na ang Faberco," he confirmed to ABS-CBN News in a separate text message.
"Last week, nag-apply na ang Faberco," he confirmed to ABS-CBN News in a separate text message.
Faberco also applied as a "distributor of one of the licensee manufacturers of Merck," he added.
Faberco also applied as a "distributor of one of the licensee manufacturers of Merck," he added.
Faberco's head of communications Neil Maristela said the FDA received their EUA application last week. Their firm is applying as the sole EUA applicant, and not in behalf of Merck, he clarified.
Faberco's head of communications Neil Maristela said the FDA received their EUA application last week. Their firm is applying as the sole EUA applicant, and not in behalf of Merck, he clarified.
"It is still under evaluation so there's no document yet... They (FDA) are in the process of evaluation as we speak. We hope the approval will be very soon!" Maristela said.
"It is still under evaluation so there's no document yet... They (FDA) are in the process of evaluation as we speak. We hope the approval will be very soon!" Maristela said.
The COVID-19 antiviral drug is not commercially available yet in the country, he pointed out, but it is accessible to several hospitals that have compassionate special permit for it.
The COVID-19 antiviral drug is not commercially available yet in the country, he pointed out, but it is accessible to several hospitals that have compassionate special permit for it.
The FDA earlier approved the "compassionate use" of Molnupiravir for 31 hospitals in the Philippines.
The FDA earlier approved the "compassionate use" of Molnupiravir for 31 hospitals in the Philippines.
The initial shipment of the drug arrived in the Philippines earlier in the day, Faberco also confirmed.
The initial shipment of the drug arrived in the Philippines earlier in the day, Faberco also confirmed.
Merck earlier said it was expecting to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022.
Merck earlier said it was expecting to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022.
The FDA earlier approved the emergency use of COVID-19 treatment drug Ronapreve in October, the first to get such grant locally.
The FDA earlier approved the emergency use of COVID-19 treatment drug Ronapreve in October, the first to get such grant locally.
It is also called REGEN-COV in the United States, manufactured by Roche.
It is also called REGEN-COV in the United States, manufactured by Roche.
—With a report from Reuters
This article corrects the earlier published version which stated that Merck applied for the EUA in the country. The US-based firm said the supply of molnupiravir in the Philippines is possible through their voluntary licensing manufacturers and its sub-licensed manufacturers that they agreed with under the medicines patent tool. We apologize for the error.
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Molnupiravir
COVID19
coronavirus
COVID-19
Food and Drug Administration
Merck
molnupiravir merck
molnupiravir EUA
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