FDA approves more brands of molnupiravir, OKs local manufacturing | ABS-CBN
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FDA approves more brands of molnupiravir, OKs local manufacturing
FDA approves more brands of molnupiravir, OKs local manufacturing
Gillan Ropero,
ABS-CBN News
Published Feb 09, 2022 12:29 PM PHT
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Updated Feb 09, 2022 05:21 PM PHT

MANILA (UPDATE) - The Food and Drug Administration has approved the emergency use of more brands of COVID-19 drug molnupiravir, including a local manufacturer, and is evaluating Pfizer's COVID-19 treatment course Paxlovid, its chief said Wednesday.
MANILA (UPDATE) - The Food and Drug Administration has approved the emergency use of more brands of COVID-19 drug molnupiravir, including a local manufacturer, and is evaluating Pfizer's COVID-19 treatment course Paxlovid, its chief said Wednesday.
FDA officer-in-charge Oscar Gutierrez, in a taped public briefing with President Rodrigo Duterte, said the following brands have received emergency use authorization:
FDA officer-in-charge Oscar Gutierrez, in a taped public briefing with President Rodrigo Duterte, said the following brands have received emergency use authorization:
- Molnarz (Faberco)
- Molnaflu (Medethix)
- Auxilto (German Quality Pharma)
- Molxvir (Sun Pharma)
- Molnatris (Mykan)
- Molnupiravir Generic (Lloyd Laboratories/Dr. Zen’s Research)
- Molnarz (Faberco)
- Molnaflu (Medethix)
- Auxilto (German Quality Pharma)
- Molxvir (Sun Pharma)
- Molnatris (Mykan)
- Molnupiravir Generic (Lloyd Laboratories/Dr. Zen’s Research)
Lloyd Laboratories can produce 1 million capsules per year that can cater to 25,000 to 50,000 COVID-19 patients, according to Gutierrez.
Lloyd Laboratories can produce 1 million capsules per year that can cater to 25,000 to 50,000 COVID-19 patients, according to Gutierrez.
Generic products are usually sold for 30 percent to 50 percent less the price of branded ones, he said. Products granted an EUA can only be bought by the national government, Gutierrez added.
Generic products are usually sold for 30 percent to 50 percent less the price of branded ones, he said. Products granted an EUA can only be bought by the national government, Gutierrez added.
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"Ide-deliver po ito ng DOH (Department of Health) sa health facilities and healthcare providers. Sila po ang maga-administer at magpo-provide nito sa mga pasyente," he said in a televised public briefing Wednesday.
"Ide-deliver po ito ng DOH (Department of Health) sa health facilities and healthcare providers. Sila po ang maga-administer at magpo-provide nito sa mga pasyente," he said in a televised public briefing Wednesday.
(These will be delivered by the DOH to health facilities and healthcare providers, which will administer and provide these to patients.)
(These will be delivered by the DOH to health facilities and healthcare providers, which will administer and provide these to patients.)
Molnupiravir is a prescription drug used to treat mild to moderate COVID-19 patients, Gutierrez said.
Molnupiravir is a prescription drug used to treat mild to moderate COVID-19 patients, Gutierrez said.
"Kailangan inumin po ito ng pasyente (The patient should take this) under the strict supervision po ng (of a) physician," he said.
"Kailangan inumin po ito ng pasyente (The patient should take this) under the strict supervision po ng (of a) physician," he said.
The FDA has also approved the antigen self-test kit of Getein Biotech Incorporated, Gutierrez said. It has forwarded some 54 self-test kits to the Research Institute for Tropical Medicine for performance validation, he added.
The FDA has also approved the antigen self-test kit of Getein Biotech Incorporated, Gutierrez said. It has forwarded some 54 self-test kits to the Research Institute for Tropical Medicine for performance validation, he added.
"Kung iyong applicant po na finorward namin iyong produkto for performance validation ay hindi po agad makapag-comply ng requirements ng RITM for evaluation, posible po na hindi po talaga maiisyuhan ng performance validation iyon," he said.
"Kung iyong applicant po na finorward namin iyong produkto for performance validation ay hindi po agad makapag-comply ng requirements ng RITM for evaluation, posible po na hindi po talaga maiisyuhan ng performance validation iyon," he said.
(If the applicant does not comply with RITM's requirements for evaluation, it's possible it would not be issued a performance validation
(If the applicant does not comply with RITM's requirements for evaluation, it's possible it would not be issued a performance validation
Meantime, Pfizer has submitted its application for emergency use authorization of Paxlovid, Gutierrez said.
Meantime, Pfizer has submitted its application for emergency use authorization of Paxlovid, Gutierrez said.
"Under evaluation na rin po ito. So puwede ako magbigay ng update uli sa darating na mga araw," he said during Duterte's "Talk To The People" that aired Monday.
"Under evaluation na rin po ito. So puwede ako magbigay ng update uli sa darating na mga araw," he said during Duterte's "Talk To The People" that aired Monday.
(It's now under evaluation. I can give updates in the coming days.)
(It's now under evaluation. I can give updates in the coming days.)
Video courtesy of PTV
Read More:
molnupiravir
FDA
Food and Drug Administration
molnupiravir generic
molnatris
molxvir
auxilto
molnaflu
molnarz
emergency use authorization
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