The Food and Drug Administration has permanently canceled the certificates of product registration of the anti-dengue vaccine Dengvaxia over the continued failure of its manufacturer, Sanofi Pasteur Inc., to submit post-approval commitment documents.
In a statement Tuesday, FDA Director General Nela Charade G. Puno accused the giant French pharmaceutical firm of continuously defying 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.” Puno said.
READ: FDA to decide whether to register Dengvaxia vaccine for anti-dengue
In an order signed by Puno Dec. 21, 2018, the FDA ordered Sanofi to immediately surrender the original CPRs of its Dengvaxia-based products.
FDA pointed out that as of Dec. 17, 2018, its Center for Drug Regulation and Research, in coordination with its Task Force Dengvaxia, confirmed that Sanofi has still not submitted its post-marketing authorization requirements.
READ: Aquino, Sanofi execs rapped over Dengvaxia
The FDA also reminded Sanofi that pursuant to the revocation of the CPRs, it is unlawful to import, sell, or distribute the products.
The CDRR is also directed to defer the processing of any submission and application by Sanofi regarding Dengvaxia and Dengvaxia-MD.
The FDA had initially suspended the CPR for Dengvaxia in 2017 and ordered Sanofi to comply with its directives.
Meanwhile, the Department of Health reported that the cases of measles have grown to more than 8,000 as of Feb. 17, resulting in 136 deaths.
Health officials were considering declaring a measles outbreak in Cagayan Valley if the disease continues to spread.
READ: ‘Dengvaxia cases up for decision’
READ: Govt to sue to regain Dengvaxia payments