Influenza Virus Vaccine - Flu-Immune
Status: withdrawn from the market
Organizations involved:
Lederle Labs. – Manuf.; R&D; Tech.; Former
Wyeth Pharmaceuticals – Parent co.; USA mark.; Former
Cross ref: See the Influenza Virus Vaccines entry (#470).
Cross ref: See the entries for Influenza Vaccine Products and the other influenza vaccine from Wyeth (#425).
Description: Flu-Immune was a conventional trivalent inactivated split (subvirion) influenza virus vaccine.
Nomenclature: Influenza Vaccine/Lederle [BIO]; Flu-Immune [TR]; Influenza Virus Vaccine [FDA USAN]; Influenza Virus Vaccine USP [USP]
Companies.: The vaccine was manufactured by Lederle Labs. (formerly subsidiary of American Cyanamid Co.; acquired by American Home Products Corp., now Wyeth), FDA CBER est. no. 0017. The 2001-2002 flu season was apparently the last Flu-Immune was manufactured/marketed. Flu-Immune was marketed by Wyeth in the U.S., and perhaps internationally
FDA class: Biologic PLA
CBER class: Viral And Rickettsial Vaccines
Indications: active immunization for prophylaxis against influenza virus infections
Status: Product license was recently voluntarily revoked (last reported as valid in 4/2004), and the product is no longer manufactured or marketed. In Nov. 2002, Wyeth announced halt of future manufacture of inactivated influenza vaccines to concentrate on marketing of FluMist, a live intranasal influenza vaccine (see #175), from MedImmune. Wyeth dropped marketing of FluMist after a disastrous product launch in the 2003-4 flu season.
Companies involvement:
Full monograph
479 Influenza Vaccine/Lederle
Nomenclature:
Influenza Vaccine/Lederle [BIO]
Flu-Immune [TR]
Influenza Virus Vaccine [FDA USAN]
Influenza Virus Vaccine USP [USP]
FDA Class: Biologic PLA
Year of approval (FDA) = 1945
Date of 1st FDA approval = 19451207
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
chicken source materials
vaccines, subunit
vaccines, viral
allantoic fluid
chicken embryo (egg) culture
influenza virus
virus culture
ethyl ether
hemagglutinin (HA) antigen, influenza A virus
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
North American coral snake
North American coral snake
EU000 Not yet/Never filed with EU
UM999 Not Available/Not Marketed in US
US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
Copyright© 2020, Biotechnology Information Institute