OMONTYS

OMONTYS

  • 5/28/2012
  • Affymax and Takeda
  • Peginesatide 2mg, 3mg, 4mg, 5mg, 6mg per 0.5mL single-use vial (preservative-free); 1mg, 2mg, 3mg, 4mg, 5mg, 6mg per 0.5mL single-use prefilled syringe (preservative-free); 10mg/mL, 20mg/2mL multiple-use vial (w. preservatives); solution for IV or SC injection.
  • Anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
FERRIPROX

FERRIPROX

  • 1/30/2012
  • ApoPharma USA Inc.
  • Deferiprone 500mg; scored tabs.
  • Treatment of transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.
FIRAZYR

FIRAZYR

  • 11/18/2011
  • Shire US, Inc.
  • Icatibant 10mg/mL; soln for SC inj; preservative-free.
  • Treatment of acute attacks of hereditary angioedema (HAE).
BRILINTA

BRILINTA

  • 8/25/2011
  • AstraZeneca Pharmaceuticals
  • Ticagrelor 90mg; tablets.
  • To reduce the rate of thrombotic cardiovascular (CV) events in patients with acute coronary syndrome (ACS) (unstable angina or non-ST-elevation myocardial infarction [MI] or ST-elevation MI).
CORIFACT

CORIFACT

  • 8/18/2011
  • CSL Behring, LLC
  • Factor XIII concentrate (human); 1000–1600 units; per vial; pwd for IV inj after reconstitution; preservative-free.
  • Routine prophylactic treatment of congenital Factor XIII (FXIII) deficiency.
XARELTO

XARELTO

  • 7/28/2011
  • Janssen Therapeutics
  • Rivaroxaban 10mg; tablets.
  • To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery.
PRADAXA

PRADAXA

  • 11/12/2010
  • Boehringer Ingelheim Pharmaceuticals
  • Dabigatran etexilate mesylate 75mg, 150mg; caps.
  • To reduce risk of stroke and systemic embolism in non-valvular atrial fibrillation.