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New Drug Approvals Archive - February 2004

February 2004

Alimta (pemetrexed) Injection

Date of Approval: February 4, 2004
Company: Eli Lilly
Treatment for: Malignant Pleural Mesothelioma, Non-Small Cell Lung Cancer

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

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.

Fazaclo (clozapine) Orally Disintegrating Tablets

Date of Approval: February 9, 2004
Company: Alamo Pharmaceuticals
Treatment for: Schizophrenia

Fazaclo is an orally disintegrating atypical antipsychotic indicated for the treatment of schizophrenia.

EstroGel (estradiol topical) Gel

Date of Approval: February 9, 2004
Company: Solvay Pharmaceuticals
Treatment for: Postmenopausal Symptoms

EstroGel (estradiol) 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.

Rhophylac (Rh0(D) immune globulin intravenous (human)) Injection

Date of Approval: February 12, 2004
Company: ZLB Bioplasma AG, Switzerland
Treatment for: Prevention of Rho(D) Sensitization

Rhophylac (Rh0(D) immune globulin intravenous (human)) is indicated for the suppression of rhesus (Rh) isoimmunization in pregnancy, obstetric conditions and incompatible transfusions, and the treatment of immune thrombocytopenic purpura.

Erbitux (cetuximab) Injection

Date of Approval: February 12, 2004
Company: ImClone
Treatment for: Colorectal Cancer, Head and Neck Cancer

Erbitux is epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of colorectal cancer and Head and Neck Cancer.

Avastin (bevacizumab) Injection

Date of Approval: February 26, 2004
Company: Genentech, Inc.
Treatment for: Colorectal Cancer, Non-Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody for the treatment of colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer, fallopian tube cancer, and peritoneal cancer.

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.

Rhophylac (Rh0(D) immune globulin intravenous (human))

New Indication Approved: March 16, 2007
Treatment for: Prevention of Rho(D) Sensitization

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