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

Source: Philippine Star February 19, 2019 05:50 UTC