New Drug Approvals Archive - March 2010

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.

• FDA Approves Exaglo (hydromorphone HCl) Extended-Release Tablets

Exalgo (hydromorphone) FDA Approval History

Norditropin (somatropin [rDNA origin])

New Dosage Form Approved: March 1, 2010

• Novo Nordisk Receives FDA Approval for Norditropin FlexPro for Growth Hormone Treatment

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.

• CSL Behring Receives FDA Approval of Hizentra, First 20 Percent Subcutaneous Immunoglobulin Therapy

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

Botox (onabotulinumtoxinA)

New Indication Approved: March 9, 2010

• Botox (onabotulinumtoxinA) Receives FDA Approval for Treatment of Upper Limb Spasticity in Adults

Trelstar (triptorelin pamoate)

New Formulation Approved: March 10, 2010

• FDA Approves Watson's Trelstar 22.5 mg, the First and Only 6-Month Intramuscular GnRH Agonist for the Palliative Treatment of Advanced Prostate Cancer

Dacogen (decitabine)

New Dosage Regimen: March 11, 2010

• FDA Approves Five-Day Dosing Regimen for Dacogen (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS)

Dacogen (decitabine) FDA Approval History

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.

• Somaxon Announces FDA Approval of Silenor (doxepin) for the Treatment of Insomnia

Silenor (doxepin) FDA Approval History

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).

• FDA Approves Carbaglu to Treat Condition That Causes Elevated Ammonia Levels

Carbaglu (carglumic acid) FDA Approval History

Differin (adapalene)

New Formulation Approved: March 17, 2010

• Galderma Received FDA Approval of Differin (adapalene) Lotion, 0.1%, the First Retinoid Available in Lotion Formulation

Mirapex (pramipexole dihydrochloride)

New Indication Approved: March 19, 2010

• Once-Daily Mirapex ER Now Approved by FDA for Both Early and Advanced Parkinson's Disease

Xifaxan (rifaximin)

New Indication Approved: March 24, 2010

• FDA Approves New Use of Xifaxan for Patients with Liver Disease

Xifaxan (rifaximin) FDA Approval History

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.

• FDA Approves Zyclara (imiquimod) Cream, 3.75% for the Treatment of Actinic Keratoses

Zyclara (imiquimod) FDA Approval History

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.

• FDA Approves Asclera to Treat Small Varicose Veins

Asclera (polidocanol) FDA Approval History

Zyclara (imiquimod)

New Indication Approved: March 24, 2011

• FDA Approves Zyclara (imiquimod) Cream, 3.75% for the Treatment of External Genital Warts

Zyclara (imiquimod) FDA Approval History

Zyclara (imiquimod)

New Dosage Regimen: July 15, 2011

• FDA Approves Zyclara (imiquimod) Cream, 2.5% for the Treatment of Actinic Keratoses

Zyclara (imiquimod) FDA Approval History

Exalgo (hydromorphone)

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

• FDA Approves Mallinckrodt's Exalgo (hydromorphone HCl) Extended-Release Tablets 32 mg (CII) for Opioid-Tolerant Patients with Moderate-to-Severe Chronic Pain

Exalgo (hydromorphone) FDA Approval History