PH FDA grants special permit for generic version of Pfizer's anti-COVID drug

Medicines (File photo / MANILA BULLETIN)

The Food and Drug Administration (FDA) has granted a compassionate special permit (CSP) for coronavirus disease (COVID-19) drug Bexovid, which is the generic version of Pfizer’s COVID-19 pill Paxlovid.

“Mr. President, na-approve po ng FDA ang application ng DOH para sa compassionate special permit institutional use para maging accessible ang unang generic version ng Paxlovid (Mr. President, the FDA has approved the application of the DOH for a compassionate special permit institutional use to make the first generic version of Paxlovid accessible),” said FDA officer-in-charge Oscar Gutierrez on Monday night, Jan. 10 during President Duterte’s public address.

"Yung Bexovid po ay yung world’s first generic version of the US-FDA approved Pfizer’s Paxlovid... DOH will make this accessible and available to government hospital once the Biocare Lifescience, Inc. will deliver this to them,” he added.

This COVID-19 treatment is a combination of Nirmatrelvir and Ritonavir. This should be taken twice a day for five days. It is for patients aged 12 and above with mild to moderate COVID-19 infection, said Gutierrez.

The said COVID-19 pill was found to be effective in reducing the risk of hospitalization or death, said DOH Undersecretary Leopoldo Vega.

“Na-examine at na-research doon sa Pfizer, sa USA---nakita nila sa data nila sa lahat ng mga pasyenteng nabigyan po nito, nag-reduce ang kanilang hospitalization and death to about 90 percent (It was examined and researched by Pfizer in the USA --- they found in their data that on all the patients who were given it, it reduced their hospitalization and death to about 90 percent),” said Vega in during the Malacanang press briefing on Tuesday, Jan. 11.