Bulletin of the World Health Organization

An antibiotic’s journey from marketing authorization to use, Norway

Christine Årdal, Hege Salvesen Blix, Jens Plahte & John-Arne Røttingen

Volume 95, Number 3, March 2017, 220-226

Table 1. Novel antibiotics awarded marketing authorization, Norway, 2005–2015

Generic chemical name Brand name: formulation, package size Type of antibiotica Reimbursement by Norwegian national insurance scheme Year of marketing authorizationb Maximum price per package, US$c Reimbursed amount per package, US$c Included in community practice guidelines Included in hospital guidelines No. of packages sold in 2014d No. of packages sold in 2015d
Ceftaroline fosamil Zinforo: 600 mg, powder for infusion, 10 vials Broad-spectrum Yes 2012 985 985 No No 39 42
Ceftolozane–tazobactam Zerbaxa: 1 g ceftolozane and 0.5 g tazobactam, powder for infusion, 10 vials Broad-spectrum No 2015 1336 0 No No N/A 0
Daptomycin Cubicin: 350 mg or 500 mg, powder for infusion, 1 viale Narrow-spectrum Yes 2006 178f 178 No Yes 482 646
Fidaxomicin Dificlir: 200 mg, 20 tablets Pathogen-specific No 2011 1952 0 No Yes 49 63
Levofloxacing Levofloxacin B.Braun: 5 mg/mL, solution for infusion, 20 × 100 mL vials Broad-spectrum Yes 2013 180 180 No Yes 49 0
Retapamulin Altargo: 1% ointment 5 g Narrow-spectrum No 2007 18 0 Yes Yes 1708 2107
Rifaximin Xifaxan: 550 mg, 56 tablets Broad-spectrum Yes 2013 390 390 No No 338 896
Tedizolid Sivextro: 200 mg, powder for infusion, 6 vials (or 6 200-mg tablets) Narrow-spectrum Yes 2015 1778h 1778 No No N/A 0
Tigecycline Tygacil: 50 mg, powder for infusion, 10 vials Broad-spectrum Yes 2006 614 614 No Yes 131 74

N/A: not applicable; US$: United States dollar.

a A narrow-spectrum antibiotic is effective against only either Gram-negative or Gram-positive bacteria, whereas a broad-spectrum antibiotic is effective against both.

b The year in which the antibiotic became available on the Norwegian market may have been later.

c Prices have been converted from Norwegian kroner at a rate of 8 kroner to 1 United States dollar.

d Data from the Norwegian drug wholesale statistics database.10

e The 350-mg vial was withdrawn from the market in 2010.

f Price is for the 500-mg vial.

g Although levofloxacin received marketing authorization in the United States in 1996, it did not gain Norwegian marketing authorization until 2013. Some versions of levofloxacin without marketing authorization were sold in Norway in 2014 and 2015 – they are not included in the table.

h Same price for both powder and tablets.

Note: Doripenem received marketing authorization in 2009 but was withdrawn from the market in 2014.