New Drug Approvals Archive - February 2011

Makena (hydroxyprogesterone caproate) Injection - formerly Gestiva

Date of Approval: February 3, 2011
Company: Hologic, Inc.
Treatment for: Premature Labor

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.

• FDA Approves Makena to Reduce Risk of Preterm Birth in At-Risk Pregnant Women

Makena (hydroxyprogesterone caproate) FDA Approval History

Reyataz (atazanavir sulfate)

Labeling Revision Approved: February 4, 2011

• Reyataz (atazanavir) label revised, adding dosing recommendations for pregnancy and postpartum period

Corifact (factor XIII concentrate (human))

Date of Approval: February 17, 2011
Company: CSL Behring LLC
Treatment for: Factor XIII Deficiency

Corifact (factor XIII concentrate (human)) is a is a fibrin-stabilizing factor concentrate indicated to prevent bleeding in people with congenital Factor XIII deficiency.

• FDA Approves Corifact to Prevent Bleeding in People With Rare Genetic Defect

Corifact (factor XIII concentrate (human)) FDA Approval History

Abilify (aripiprazole)

Labeling Revision Approved: February 16, 2011

• Abilify (aripiprazole) Approved for Maintenance Treatment of Bipolar I Disorder as an Adjunct to Either Lithium or Valproate

Edarbi (azilsartan medoxomil) Tablets

Date of Approval: February 25, 2011
Company: Takeda Pharmaceutical Company Limited
Treatment for: Hypertension

Edarbi (azilsartan medoxomil) is an angiotensin II receptor blocker (ARB) for the treatment of hypertension.

• FDA Approves Edarbi to Treat High Blood Pressure

Edarbi (azilsartan medoxomil) FDA Approval History

Daliresp (roflumilast) Tablets - formerly Daxas

Date of Approval: February 28, 2011
Company: Allergan, Inc.
Treatment for: Chronic Obstructive Pulmonary Disease

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.

• FDA Approves Daliresp to Treat Chronic Obstructive Pulmonary Disease

Daliresp (roflumilast) FDA Approval History