Sanofi Pasteur Korea said Friday that it plans to pull their Intradermal (ID) Flu product from Korea.
The decision comes after the Ministry of Food and Drug Safety 식품의약품안전처 dealt sales suspension of the drug for six months for failing to apply for reexamination.
|Intradermal (ID) Flu vaccine|
The company 사노피파스퇴르 said that the administrative suspension does not imply that it would neglect the flu vaccine need in the Korean market, in an interview with the Korea Biomedical Review.
“The decision not to reapply is not a mistake on our part,” a company official said. “ID Flu aims to vaccinate patients over 60, but Sanofi Pasteur already has Vaxigrip, a trivalent vaccine, and VaxigripTetra, a quadrivalent vaccine, for all patients here.”
ID Flu has not been released in the domestic market since it received items approval from the ministry in 2010.
“After deciding to cancel the item approval we discussed the matter with related governmental authorities,” said the official. “The governmental recommended the company to not submit for reexamination as part of getting the approval canceled.” The company plans to take appropriate steps to withdraw their item approval, she added.
As Sanofi Pasteur Korea began to release VaxigripTetra and Vaxigrip last month, the company expects the withdrawal of ID Flu will not affect its supply of flu vaccines in the domestic market, the official said.
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