New Drug Approvals Archive - 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.

• Uroxatral Sanofi Synthelabo - Treatment for Benign Prostatic Hyperplasia (BPH)

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.

• FluMist MedImmune Vaccines, Inc - Treatment for Prevention of Influenza

Xolair (omalizumab) Subcutaneous Injection

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

Xolair (omalizumab) is a monoclonal antibody indicated for the treatment of patients with moderate to severe persistent asthma, and chronic idiopathic urticaria.

• Xolair Genentech, Inc. - Treatment for Asthma

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.

• Reyataz Bristol Myers Squibb - Treatment for HIV Infection

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.

• Bexxar Corixa Corporation - Treatment for Non-Hodgkin’s Lymphoma

Reyataz (atazanavir sulfate)

Patient Population Altered: September 30, 2008

• U.S. Food & Drug Administration Approved the use of Reyataz (atazanavir sulfate) Boosted with Ritonavir, in Combination Therapy, for Previously Untreated HIV-1 Infected Adult Patients

Reyataz (atazanavir sulfate)

Labeling Revision Approved: November 5, 2009

• FDA Approves Labeling Update for Reyataz (atazanavir sulfate) Capsules to Include 96-Week Data for Previously Untreated HIV-1 Infected Adult Patients

Reyataz (atazanavir sulfate)

Labeling Revision Approved: February 4, 2011

• Reyataz (atazanavir) label revised, adding dosing recommendations for pregnancy and postpartum period

FluMist (Influenza Virus Vaccine, Live, Intranasal)

New Formulation Approved: March 1, 2012

• FDA Approves FluMist Quadrivalent Vaccine to Prevent Seasonal Influenza

Xolair (omalizumab)

New Indication Approved: March 21, 2014

• FDA Approves Xolair (omalizumab) for Chronic Idiopathic Urticaria

Xolair (omalizumab)

Patient Population Altered: July 7, 2016

• FDA Approves Genentech’s Xolair (omalizumab) for Allergic Asthma in Children