New Drug Approvals Archive - July 2003

Emtriva (emtricitabine) Capsules

Date of Approval: July 2, 2003
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Emtriva (emtricitabine) is a nucleoside reverse transcriptase inhibitor (NRTI) used with other anti-HIV medicines to treat people with HIV infection.

• Emtriva Gilead Sciences, Inc. - Treatment for HIV Infection

Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%) Otic Suspension

Date of Approval: July 18, 2003
Company: Alcon Research, Ltd.
Treatment for: Acute Otitis Externa, Otitis Media

Ciprodex (ciprofloxacin/dexamethasone) is an antibiotic / anti-inflammatory combination used for the treatment of acute otitis media and acute otitis externa.

• Ciprodex Alcon Research, Ltd. - Treatment for Ear Infections

Clobex (clobetasol propionate) Lotion

Date of Approval: July 24, 2003
Company: Galderma Laboratories
Treatment for: Atopic Dermatitis, Psoriasis

Clobex (clobetasol) is a topical corticosteroid used to treat steroid-responsive dermatoses including moderate-to-severe atopic dermatitis and moderate-to-severe psoriasis.

• Clobex Galderma Laboratories - Treatment for Inflammatory Skin Conditions

Advate (antihemophilic factor [recombinant])

Date of Approval: July 25, 2003
Company: Baxter Healthcare Corp
Treatment for: Hemophilia A

Advate (antihemophilic factor [recombinant]) is indicated for use in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes, and also indicated in the perioperative management of patients with hemophilia A.

• Advate Baxter Healthcare Corp - Treatment for Hemophilia A

Aloxi (palonosetron) Injection

Date of Approval: July 25, 2003
Company: Helsinn Healthcare
Treatment for: Nausea/Vomiting -- Chemotherapy Induced

Aloxi (palonosetron) is a 5-HT3 receptor antagonist indicated for the prevention of nausea and vomiting associated with chemotherapy.

• FDA Approves Aloxi for Chemotherapy-Induced Nausea and Vomiting (CINV)

Zavesca (miglustat) Capsules

Date of Approval: July 31, 2003
Company: Actelion Pharmaceuticals
Treatment for: Gaucher Disease

Zavesca (miglustat) is a glucosylceramide synthase inhibitor indicated for the treatment of adult patients with mild to moderate type 1 Gaucher disease.

• Zavesca Actelion Pharmaceuticals - Treatment for Type 1 Gaucher Disease

Clobex (clobetasol propionate) Lotion

Date of Approval: July 24, 2003
Company: Galderma Laboratories
Treatment for: Atopic Dermatitis, Psoriasis

Clobex (clobetasol) is a topical corticosteroid used to treat steroid-responsive dermatoses including moderate-to-severe atopic dermatitis and moderate-to-severe psoriasis.

• Clobex Galderma Laboratories - Treatment for Scalp Psoriasis

Aloxi (palonosetron)

New Dosage Regimen: August 30, 2007

• MGI Pharma and Helsinn Announce Aloxi sNDA Approval Allowing for Repeated Dosing for Cancer Patients Receiving Multiple Day Chemotherapy Regimens

Aloxi (palonosetron)

New Indication Approved: February 29, 2008

• FDA Approves Aloxi (palonosetron HCl) Injection for Prevention ofPostoperative Nausea and Vomiting

Aloxi (palonosetron)

New Dosage Form Approved: August 22, 2008

• FDA Approves Aloxi (palonosetron HCl) Capsules for Prevention of Acute Chemotherapy-induced Nausea and Vomiting