MANILA, Philippines — The Food and Drug Administration (FDA) has permanently revoked the certificates of product registration (CPRs) it previously issued to Dengvaxia products after its manufacturer failed to submit post-approval commitment documents. According to FDA, it has ordered Sanofi Pasteur on December 21, 2018 to “immediately surrender” the original CPRs of Dengvaxia products – Dengue Tetravalent (Live Attenuated), Dengvaxia MD and Dengue Tetravalent Vaccine (Live Attenuated) (Dengvaxia). Moreover, FDA said Sanofi Pasteur has yet to submit and comply with its post marketing authorization requirements as of December 17, 2018. To recall, FDA initially suspended the CPR of Dengvaxia in 2017, and directed Sanofi Pasteur to halt the sale, distribution, or marketing of Dengvaxia. With the revocation of CPRs for Dengvaxia products, Sanofi Pasteur is prohibited from importing, selling or distributing Dengue Tetravalent (Live Attenuated), Dengvaxia MD and Dengue Tetravalent Vaccine (Live Attenuated) (Dengvaxia), FDA said.

Source: Philippine Daily Inquirer February 19, 2019 05:37 UTC