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New Drug Approvals Archive - February 2008

February 2008

February 4

Asmanex (mometasone furoate)

Patient Population Altered: February 4, 2008

Asmanex (mometasone furoate) FDA Approval History

February 15

Simcor (niacin ER and simvastatin) Tablets

Date of Approval: February 15, 2008
Company: Abbott
Treatment for: Hyperlipidemia

Simcor (niacin extended-release/simvastatin) is a fixed-dose combination lipid therapy used along with diet to lower levels of total cholesterol, LDL "bad" cholesterol and triglycerides, and to increase HDL "good" cholesterol.

Simcor (niacin ER and simvastatin) FDA Approval History

February 19

Xyzal (levocetirizine dihydrochloride)

New Dosage Form Approved: January 28, 2008

Xyzal (levocetirizine dihydrochloride) FDA Approval History

February 21

Xyntha (antihemophilic factor (recombinant), plasma/albumin free )

Date of Approval: February 21, 2008
Company: Wyeth Pharmaceuticals Inc.
Treatment for: Hemophilia A

Xyntha (Antihemophilic Factor (Recombinant) Plasma/Albumin Free) is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Xyntha is indicated for the control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A.

Xyntha (antihemophilic factor (recombinant), plasma/albumin free ) FDA Approval History

February 22

Humira (adalimumab)

New Indication Approved: February 21, 2008

February 25

Avastin (bevacizumab)

New Indication Approved: February 22, 2008

Avastin (bevacizumab) FDA Approval History

February 28

Nexium (esomeprazole)

New Dosage Form Approved: February 27, 2008

February 27

Arcalyst (rilonacept) Injection - formerly Interleukin-1 Trap

Date of Approval: February 27, 2008
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Cryopyrin-Associated Periodic Syndromes

Arcalyst (rilonacept) is an interleukin-1 inhibitor for the long-term treatment of Cryopyrin-Associated Periodic Syndromes (CAPS).

Arcalyst (rilonacept) FDA Approval History

February 29

Abilify (aripiprazole)

Patient Population Altered: February 27, 2008

February 29

Pristiq (desvenlafaxine) Extended-Release Tablets

Date of Approval: February 29, 2008
Company: Wyeth Pharmaceuticals
Treatment for: Depression

Pristiq (desvenlafaxine) is a serotonin-norepinephrine reuptake inhibitor (SNRI) approved for the treatment for adult patients with major depressive disorder. Pristiq is also currently under review as a treatment for moderate-to-severe vasomotor symptoms associated with menopause.

Pristiq (desvenlafaxine) FDA Approval History

July 29

Simcor (niacin ER and simvastatin)

New Dosage Form Approved: July 28, 2010

Simcor (niacin ER and simvastatin) FDA Approval History

New Drug Approvals Archive