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, Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Hizentra (immune globulin subcutaneous (human)) is an immune globulin indicated for the treatment of primary immunodeficiency, and for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.

• 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

Hizentra (immune globulin subcutaneous (human))

New Indication Approved: March 15, 2018

• FDA Approves Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
• Hizentra (immune globulin subcutaneous (human)) FDA Approval History