MANILA, Philippines — Pharmaceutical firm Sanofi Pasteur said it has filed for a motion for reconsideration after the country’s Food and Drug Administration permanently revoked the certificates of product registration of dengue vaccine Dengvaxia. FDA Director General Nela Charade Puno on Tuesday said 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. With the revocation of Dengvaxia, it is now unlawful to import, sell or distribute the said products. The pharmaceutical firm stressed that the country’s FDA is not questioning the safety and efficacy of Dengvaxia with the revocation of the product’s CPR.

Source: Philippine Star February 19, 2019 10:34 UTC