New Drug Approvals Archive

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February 2011

February 3

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.

Makena (hydroxyprogesterone caproate) FDA Approval History

February 7

Reyataz (atazanavir sulfate)

Labeling Revision Approved: February 4, 2011

February 17

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.

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

February 18

Abilify (aripiprazole)

Labeling Revision Approved: February 16, 2011

February 25

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.

Edarbi (azilsartan medoxomil) FDA Approval History

February 28

Daliresp (roflumilast) Tablets - formerly Daxas

Date of Approval: February 28, 2011
Company: Forest Pharmaceuticals, 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.

Daliresp (roflumilast) FDA Approval History

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