Influenza vaccine, MDCK cultured/Novartis
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Flucelvax; Optaflu; Influenza virus vaccine, inactivated
Status: approved in the EU in 2007; U.S. filing had been expected as early as 2008
Organizations involved:
Chiron Corp. – R&D; Tech.; Former
Novartis AG – Manuf.; R&D; Tech.; World mark.
MedImmune, Inc. – Tech
Astra Zeneca plc – Parent
Cross ref.: See also the entry for Influenza Vaccine, H5N1/Novartis, which is essentially Optaflu but containing a single H1N1 (swine flu) influenza strain.
Description: Flucelvax or Optaflu is a cell cultured trivalent detergent-disrupted (inactivated) seasonal split-virion (subunit, not whole virus) influenza virus vaccine cultured in Madin Darby Canine Kidney (MDCK) cells in phosphate buffered saline (PBS). The virus is inactivated with ß-propiolactone, disrupted by the detergent cetyltrimethylammonium bromide and purified through several process steps. Each of the 3 virus strains is produced and purified separately then pooled to formulate the trivalent vaccine.
This is the first cell cultured influenza vaccine approved in a major market. As with other seasonal trivalent influenza vaccines,
Flucelvax/Optaflu contains 15 mg/doses of hemagglutinin (HA) antigen (4
... truncated (just the beginning)
Annual sales (2008; $million): (reserved for subscribers)
Annual sales (2009; $million): (reserved for subscribers)
Annual sales (2010; $million): (reserved for subscribers)
Annual sales (2011; $million): (reserved for subscribers)
Annual sales (2012; $million): (reserved for subscribers)
Index Terms:
Companies involvement:
Partial monograph text:
481 Influenza Vaccine, MDCK/Novartis
Nomenclature:
NDc 63851-611-01; NDC 63851-611-11 []
Influenza vaccine, MDCK cultured/Novartis [BIO]
Optaflu [TR]
Flucelvax [TR US]
Influenza Virus Vaccine [FDA]
FDA Class: Biologics BLA
Year of approval (FDA) = 2012
Annual sales (2007; $million): (reserved for subscribers)
Biosimilars/biobetters Data
U.S.A.
European Union (EU)
Biosimilars/biobetters-related U.S. Patents: Reserved for subscribers]
U.S. Patent Expiration Year: Reserved for subscribers
U.S. Biosimilars Data Exclusivity Expiration: Reserved for subscribers
U.S. Biosimilars Orphan Exclusivity Expiration: Reserved for subscribers
U.S. Biosimilars Launchability Year: Reserved for subscribers
U.S. Biobetters Launchability Year: Reserved for subscribers
Biosimilars/biobetters-related EU Patents: Reserved for subscribers
EU Patent Expiration Year: Reserved for subscribers
EU Biosimilars Data Exclusivity Expiration: Reserved for subscribers
EU Biosimilars Orphan Exclusivity Expiration: Reserved for subscribers
EU Biosimilars Launchability Year: Reserved for subscribers
EU Biobetters Launchability Year: Reserved for subscribers
biopharmaceutical products
chicken source materials
vaccines, inactivated
vaccines, subunit
influenza virus
insulin, bovine
Mab 1129, murine monoclonal antibody
mammalian cell culture
virus culture
virus culture
beta-propiolactone (BPL; beta propiolactone)
cesium chloride (CsCl)
cesium chloride (CsCl)
deoxyribonuclease (DNase)
influenza prophylaxis
phosphate buffered saline (PBS)
apheresis (hemapheresis)
North American coral snake
EU200 Currently Approved in EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM001 Marketed Product in EU
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