MANILA, Philippines — Citing the continued failure of pharmaceutical firm Sanofi Pasteur to submit post-approval commitment documents, the Food and Drug Administration decided to permanently revoke the certificates of product registration for dengue vaccine Dengvaxia.

According to FDA Director General Nela Charade Puno, the pharmaceutical company has shown complete disregard of government 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," Puno said in a statement released Tuesday.

The CPR for the dengue vaccine was initially suspended for one year since Dec. 29, 2017, after Sanofi's failure to comply with post-marketing requirements.

Prior to the lapse of the one-year suspension on Dec. 17, 2018, Sanofi failed to submit and comply with post marketing authorization requirements. The company has since then suspended the sale, distribution and marketing of the dengue vaccine.

On Dec. 21, 2018, Sanofi was ordered to surrender the original CPRs of dengue tetravalent (Dengvaxia MD) and dengue tetravalent vaccine (Dengvaxia) upon receipt of order, the FDA said.

"The FDA also reminded Sanofi that pursuant to the revocation of the CPRs, it is unlawful to import, sell, or distribute the said products," the agency said.

The FDA's Center for Drug Regulation and Research has been directed to defer any submission and application of Sanofi in relation to Dengvaxia and Dengvaxia MD.

Dengvaxia vaccination program stopped in 2017

Health Secretary Francisco Duque III suspended the dengue vaccination program in December 2017 after Sanofi admitted that it could cause severe dengue if given to those who have not had the disease.

Speaking before a Senate hearing more than a year ago, Duque said Sanofi was dishonest about the risks of Dengvaxia.

"We should not allow this. We’re talking about the lives of people here. We’re talking about the lives of our children," Duque said.