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dpa
Manila
The Philippines has revoked the registration of the world’s first dengue vaccine, amid reports of deaths allegedly related to the drug, a government agency said Tuesday.
The Food and Drug Administration (FDA) said it permanently revoked the registration of Dengvaxia after its manufacturer, French pharmaceutical company Sanofi Pasteur, failed to supply post-approval documents.
Sanofi disputed that, saying it had provided the FDA with post-approval documentation and regular updates from post-marketing studies. It said it had formally requested a reconsideration of the decision.
Manila
The Philippines has revoked the registration of the world’s first dengue vaccine, amid reports of deaths allegedly related to the drug, a government agency said Tuesday.
The Food and Drug Administration (FDA) said it permanently revoked the registration of Dengvaxia after its manufacturer, French pharmaceutical company Sanofi Pasteur, failed to supply post-approval documents.
Sanofi disputed that, saying it had provided the FDA with post-approval documentation and regular updates from post-marketing studies. It said it had formally requested a reconsideration of the decision.
