New Drug Approvals Archive - February 2011
Makena (hydroxyprogesterone caproate) Injection - formerly Gestiva
Date of Approval: February 3, 2011
Makena (hydroxyprogesterone caproate) is a long acting form of natural progesterone for the prevention of preterm birth in pregnant women with a history of at least one spontaneous preterm birth.
Reyataz (atazanavir sulfate)
Labeling Revision Approved: February 4, 2011
Corifact (factor XIII concentrate (human))
Date of Approval: February 17, 2011
Corifact (factor XIII concentrate (human)) is a is a fibrin-stabilizing factor concentrate indicated to prevent bleeding in people with congenital Factor XIII deficiency.
Labeling Revision Approved: February 16, 2011
Edarbi (azilsartan medoxomil) Tablets
Date of Approval: February 25, 2011
Edarbi (azilsartan medoxomil) is an angiotensin II receptor blocker (ARB) for the treatment of hypertension.
Daliresp (roflumilast) Tablets - formerly Daxas
Date of Approval: February 28, 2011
Daliresp (roflumilast) is an orally administered phosphodiesterase 4 (PDE4) enzyme inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.