FDA allows use of more molnupiravir brands; Pfizer seeks nod for Paxlovid
MANILA, Philippines — The Food and Drug Administration (FDA) has so far granted an emergency use authorization (EUA) to six brands of the anti-COVID drug molnupiravir.
In a taped briefing with President Rodrigo Duterte on Monday, FDA Deputy Director Oscar Gutierrez said FDA has issued an EUA for the following brands, with manufacturers in parentheses:
- Molnarz (Faberco)
- Molnaflu (Medethix)
- Auxilto (German Quality Pharma)
- Molxvir (Sun Pharma)
- Molnatris (Mykan)
- Molnupiravir Generic (Lloyd Laboratories/Dr. Zen’s Research)
According to Gutierrez, the FDA granted an EUA on Jan, 28 to local firm Lloyd Laboratories for the 200-mg and 400-mg molnupiravir capsules.
“The FDA findings are clear that it has the capacity to produce molnupiravir capsules under current good manufacturing practices and molnupiravir meets the safety and quality standard as an investigatory COVID-19 drug,” he said, speaking in a mix of English and Filipino.
Meanwhile, Pfizer had already applied for an EUA for its anti-viral pill Paxlovid, according to Gutierrez.
The application is currently undergoing evaluation, he said.
The FDA will continue to receive and approve compassionate special permit applications within the next three months to augment the supply of investigatory COVID-19 drugs in the Philippines.
Gutierrez added that the FDA had approved another brand of self-administered COVID-19 antigen test kits.
With the new approved brand, there are currently three brands of antigen self-test kits that the public may buy in accredited outlets nationwide.
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