Anti-COVID drug molnupiravir shelf life extension to 12 months gets FDA OK

ANTIVIRAL PILL Molnupiravir, considered the first oral antiviral pill for mild and moderate cases of COVID-19, showed a 30-percent reduction in hospitalizations and deaths. —REUTERS

MANILA, Philippines — The Food and Drug Administration (FDA) has approved the extension of the shelf life of the anti-COVID-19 drug molnupiravir to 12 months from the previous six months, an official said Monday.

In a recorded briefing with President Rodrigo Duterte, FDA officer-in-charge Oscar Gutierrez said the agency approved the application of molnupiravir brands Molnarz and Monaflu for their emergency use authorization and extension of their product’s shelf life.

“Nag-apply sila ng extension ng kanilang shelf life. So nabigyan natin ng shelf life na hanggang 12 months, initially inaprubahan natin ng six months,” he said.

“Nagsubmit sila ng requirements so nabigyan natin sila ng 12 months. Ito ay isang magandang balita kasi meaning ‘yung gamot na ‘yun ay patuloy ang importation at magiging available sa ating mamamayan,” he said.

(They have submitted requirements so they were given 12 months. This is good news because it means that the drug would be continually imported.)

Gutierrez said nine more firms have applied for the approval of their anti-COVID-19 drugs, as well as the extension of their drugs’ shelf lives.

The FDA granted an EUA to molnupiravir in December last year.

/MUF