New Drug Approvals Archive - March 2010
See also: New Indications and Dosage Forms for March 2010
March 2010
Exalgo (hydromorphone) Extended Release Tablets
Date of Approval: March 1, 2010
Company: Covidien
Treatment for: Pain in Opioid Tolerant Patients
Marketing Status: Discontinued
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.
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.
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.
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).
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.
Asclera (polidocanol) Injection
Date of Approval: March 30, 2010
Company: Chemische Fabrik Kreussler & Co.
Treatment for: Varicose Veins
Asclera (polidocanol) is a sclerosing agent used for the treatment of varicose veins.
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