FDA OKs special permit for generic version of Pfizer’s COVID-19 pill

MANILA, Philippines — The country’s Food and Drug Administration has granted a compassionate special permit for a generic version of Pfizer’s COVID-19 pill, its chief said.

FDA officer-in-charge Oscar Gutierrez said the drug regulator has approved the application of the Department of Health for a special permit for the institutional use of Bexovid, the first generic version of Pfizer’s Paxlovid.

"The DOH will make [Bexovid] accessible and available to government hospital once the Biocare Lifescience, Inc. will deliver this to them," Gutierrez said, referring to the local distributor of the drug.

The treatment is a combination of two tablets—nirmatrelvir and ritonavir—and should be taken twice a day for five days. It is cleared for use for people aged 12 and above with mild to moderate infection.

Nirmatrelvir inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir helps nirmatrelvir to remain in the body for a longer period at higher concentrations.

The US FDA authorized the emergency use of the Pfizer pill last December.

Pfizer is expected to apply for the emergency use authorization of its pill in the Philippines by end-January, Gutierrez said. 

Bexovid is made by Beximco Pharmaceuticals, a generics and active ingredients maker in Bangladesh.