FDA says effectivity of PRODEX B, Fabunan injection vs. COVID-19 still unproven
The effectivity of PRODEX B and Fabunan Antiviral Injections against COVID-19 has yet to be proven, according to the Food and Drug Administration (FDA), contradicting information circulating on social media.
In a press statement dated April 8, the FDA said the two products are still unregistered and hence cannot be sold to the public.
"Manufacturers and vendors of unlicensed products such as PRODEX B and the Fabunan Antiviral Injections have been informed regarding the process and requirements to register their products with the FDA Center for Drug Regulation and Research (CDRR)," the FDA said.
"No applications for product registration have been filed to date."
The FDA pointed out that the two products can only be dispensed to the public and come up with therapeutic claims once they are proven safe and effective for use in the treatment of COVID-19 by the agency.
In a Facebook post on March 31, the Fabunan Medical Clinic said its antiviral injection is not commercially sold.
The injection, it said, is "used exclusively by the Fabunan Medical Clinic and its doctors, in the practice of their profession." It added that they have no sales managers.
"This is in response to reported social media posts we received," the clinic said.
The FDA, meanwhile, warned the public regarding the use of drugs or vaccines with unproven claims to be safe and effective in the treatment of COVID-19, as it noted that at present there are no registered drugs or vaccines that are licensed specifically for use in COVID-19 treatment or prevention. --KBK, GMA News