New Drug Approvals Archive

New Drug Approvals: February 2004

February 4
Alimta (pemetrexed) Injection

Date of Approval: February 4, 2004

Company: Eli Lilly

Treatment for Malignant Pleural Mesothelioma, Non-Small Cell Lung Cancer

Alimta is an antifolate antineoplastic agent indicated for the treatment of malignant pleural mesothelioma and locally-advanced and metastatic non-small cell lung cancer (NSCLC).

FDA Approves Alimta for Malignant Pleural Mesothelioma
 
February 5
Clobex (clobetasol propionate) Lotion

Date of Approval: July 24, 2003

Company: Galderma Laboratories

Treatment for Atopic Dermatitis, Psoriasis

Clobex is a Class I steroid in lotion form to help control and treat steroid-responsive dermatoses including moderate-to-severe atopic dermatitis and moderate-to-severe psoriasis.

Clobex Galderma Laboratories - Treatment for Scalp Psoriasis
 
February 5
Orthovisc (sodium hyaluronate) Injection

Date of Approval: February 4, 2004

Company: Anika Therapeutics, Inc.

Treatment for Osteoarthritis

Orthovisc is a highly purified, high molecular weight form of hyaluronic acid used for treating pain in patients suffering from osteoarthritis (OA) of the knee who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics.

Orthovisc Anika Therapeutics, Inc. - Treatment for Osteoarthritis of the Knee
 
February 9
Fazaclo (clozapine) Orally Disintegrating Tablets

Date of Approval: February 9, 2004

Company: Alamo Pharmaceuticals

Treatment for Schizophrenia

Fazaclo is an orally disintegrating tablet which dissolves quickly in the mouth (without chewing or the need for water) indicated for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatment for schizophrenia.

Fazaclo Alamo Pharmaceuticals - Treatment for Schizophrenia
 
February 9
EstroGel (estradiol topical) Gel

Date of Approval: February 9, 2004

Company: Solvay Pharmaceuticals

Treatment for Postmenopausal Symptoms

EstroGel is transdermal gel estrogen therapy for the treatment of moderate to severe vasomotor symptoms, as well as vulvar and vaginal atrophy associated with the menopause.

EstroGel Solvay Pharmaceuticals - Treatment for Menopausal Vasomotor Symptoms
 
February 12
Rhophylac () Immune Globulin Intravenous - Human) Injection

Company: ZLB Bioplasma AG, Switzerland

Treatment for Prevention of Rho(D) Sensitization

Rhophylac ZLB Bioplasma AG, Switzerland - Treatment for Prevention of Rho(D) Sensitization
 
February 12
Erbitux (cetuximab) Injection

Date of Approval: February 12, 2004

Company: ImClone

Treatment for Colorectal Cancer

Erbitux is a monoclonal antibody indicated as a combination treatment to be given intravenously with irinotecan, or alone if patients cannot tolerate irinotecan. Erbitux is approved for the treatment of patients with advanced colorectal cancer that has spread to other parts of the body.

Erbitux ImClone - Treatment for Advanced Colorectal Cancer
 
February 26
Avastin (bevacizumab) Injection

Date of Approval: February 26, 2004

Company: Genentech, Inc.

Treatment for Colorectal Cancer, Non-Small Cell Lung Cancer, Breast Cancer

Avastin is a recombinant humanized monoclonal IgG1 antibody for the treatment of metastatic colorectal cancer, non-small cell lung cancer and HER2-negative breast cancer.

Avastin Approved for treatment for Metastatic Colorectal Cancer
 
February 27
Myfortic (mycophenolic acid) Tablets

Date of Approval: February 27, 2004

Company: Novartis Pharma AG

Treatment for Organ Transplant -- Rejection Prophylaxis

Myfortic is an enteric-coated formulation of mycophenolic acid for use in combination with cyclosporine and corticosteroids to prevent organ rejection in kidney transplant patients.

Myfortic Novartis Pharma AG - Treatment for Prevention of Organ Rejection
 

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