New Drug Approvals Archive

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March 2010

March 1

Exalgo (hydromorphone) Extended Release Tablets

Date of Approval: March 1, 2010
Company: Covidien
Treatment for: Pain in Opioid Tolerant Patients

Exalgo (hydromorphone) is a once-a-day extended release opioid formulation for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

Exalgo (hydromorphone) FDA Approval History

March 3

Norditropin (somatropin [rDNA origin])

New Dosage Form Approved: March 1, 2010

March 4

Hizentra (immune globulin subcutaneous (human)) Liquid

Date of Approval: March 4, 2010
Company: CSL Behring
Treatment for: Primary Immunodeficiency Syndrome

Hizentra is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of primary immunodeficiency.

Hizentra (immune globulin subcutaneous (human)) FDA Approval History

March 10

Botox (onabotulinumtoxinA)

New Indication Approved: March 9, 2010

March 12

Dacogen (decitabine)

New Dosage Regimen: March 11, 2010

Dacogen (decitabine) FDA Approval History

March 12

Trelstar (triptorelin pamoate)

New Formulation Approved: March 10, 2010

March 17

Silenor (doxepin) Tablets

Date of Approval: March 17, 2010
Company: Somaxon Pharmaceuticals, Inc.
Treatment for: Insomnia

Silenor (doxepin) is a low-dose oral tablet formulation of the H1 receptor antagonist doxepin indicated for the treatment of insomnia characterized by difficulties with sleep maintenance.

Silenor (doxepin) FDA Approval History

March 18

Carbaglu (carglumic acid) Tablets

Date of Approval: March 18, 2010
Company: Orphan Europe
Treatment for: NAGS Deficiency Hyperammonemia

Carbaglu (carglumic acid) is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated for the treatment of hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS).

Carbaglu (carglumic acid) FDA Approval History

March 22

Differin (adapalene)

New Formulation Approved: March 17, 2010

March 24

Mirapex (pramipexole dihydrochloride)

New Indication Approved: March 19, 2010

March 25

Xifaxan (rifaximin)

New Indication Approved: March 24, 2010

Xifaxan (rifaximin) FDA Approval History

March 25

Zyclara (imiquimod) Cream

Date of Approval: March 25, 2010
Company: Graceway Pharmaceuticals, LLC
Treatment for: Keratosis, Condylomata Acuminata

Zyclara (imiquimod) is an immune response modifier indicated for the topical treatment of actinic keratoses and external genital warts.

Zyclara (imiquimod) FDA Approval History

March 30

Asclera (polidocanol) Injection

Date of Approval: March 30, 2010
Company: Chemische Fabrik Kreussler & Co.
Treatment for: Varicose Vein

Asclera (polidocanol) is a sclerosing agent used for the treatment of varicose veins.

Asclera (polidocanol) FDA Approval History

March 25

Zyclara (imiquimod)

New Indication Approved: March 24, 2011

Zyclara (imiquimod) FDA Approval History

July 29

Zyclara (imiquimod)

New Dosage Regimen: July 15, 2011

Zyclara (imiquimod) FDA Approval History

August 27

Exalgo (hydromorphone)

New Dosage Form Approved: August 27, 2012
Treatment for: Pain in Opioid Tolerant Patients

Exalgo (hydromorphone) FDA Approval History

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