FDA revokes Dengvaxia certificate
Credit to Author: Tempo Desk| Date: Tue, 19 Feb 2019 09:44:31 +0000
The Food and Drug Administration 
(FDA) has permanently revoked the certificate of product registration of the controversial anti-dengue vaccine Dengvaxia.
The FDA said on Tuesday that it revoked the product registration of Dengvaxia due to the “continued failure” of its manufacturer, French pharmaceutical giant Sanofi Pasteur, to submit to the agency “post-approval commitment documents.”
The agency said that Sanofi’s failure to comply is a “complete disregard of FDA rules and regulations.”
“Its brazen defiance of FDA’s directives and its continued failure to comply leaves us no other recourse but to impose the maximum penalty of revocation of the CPRs covering the Dengvaxia products,” said FDA Director General Nela Charade Puno in a statement.
“As of December 17, 2018, the Center for Drug Regulation Research (CDRR), in coordination with its Task Force Dengvaxia, confirmed that Sanofi has still not submitted and continued its failure to comply with its post marketing authorization requirements,” added Puno.
The agency initially suspended the controversial vaccine’s certificate of product registration in 2017, with Sanofi directed to suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of the vaccine in the market pending compliance with the directives of the FDA.
Pursuant to the revocation of the Dengvaxia’s certificate of product registration, “it is unlawful to import, sell, or distribute the said products,” the FDA said.
The Department of Health (DoH), meanwhile, welcomed the decision of the FDA.
“We’ve always agreed that that will be the direction to go because we’ve always felt that the product that was sold to us was without complete information,” said Health Undersecretary Rolando Enrique Domingo. (Analou de Vera)