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New Drug Approvals Archive - June 2003

June 2003

Uroxatral (alfuzosin) Extended-Release Tablets

Date of Approval: June 12, 2003
Company: Sanofi Synthelabo
Treatment for: Benign Prostatic Hyperplasia

Uroxatral (alfuzosin) an alpha-1-adrenergic receptor antagonist, is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.

FluMist (Influenza Virus Vaccine, Live, Intranasal)

Date of Approval: June 17, 2003
Company: MedImmune Vaccines, Inc
Treatment for: Influenza Prophylaxis

FluMist is a live trivalent nasally administered vaccine intended for active immunization for the prevention of influenza.

Reyataz (atazanavir sulfate) Capsules

Date of Approval: June 20, 2003
Company: Bristol Myers Squibb
Treatment for: HIV Infection

Reyataz is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Xolair (omalizumab) Subcutaneous Injection

Date of Approval: June 20, 2003
Company: Genentech, Inc.
Treatment for: Asthma -- Maintenance, Urticaria, Nasal Polyps

Xolair (omalizumab) is an anti-IgE monoclonal antibody indicated for:
  • moderate to severe persistent asthma in patients 6 years of age and older
  • chronic idiopathic urticaria in adults and adolescents 12 years of age and older
  • nasal polyps in adult patients 18 years of age and older.

Bexxar (Tositumomab and Iodine I 131 Tositumomab)

Date of Approval: June 27, 2003
Company: Corixa Corporation
Treatment for: non-Hodgkin's Lymphoma

Bexxar is a dual-action therapy that combines the tumor-targeting ability of a cytotoxic monoclonal antibody and the therapeutic potential of radiation. Bexxar is indicated for the treatment of Non-Hodgkin’s lymphoma.

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