New Drug Approvals Archive - 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).

• FDA Approves Alimta for Malignant Pleural Mesothelioma

Alimta (pemetrexed) FDA Approval History

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

Orthovisc (sodium hyaluronate) FDA Approval History

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.

• Fazaclo Alamo Pharmaceuticals - Treatment for Schizophrenia

Fazaclo (clozapine) FDA Approval History

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.

• EstroGel Solvay Pharmaceuticals - Treatment for Menopausal Vasomotor Symptoms

EstroGel (estradiol topical) FDA Approval History

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.

• Rhophylac ZLB Bioplasma AG, Switzerland - Treatment for Prevention of Rho(D) Sensitization

Rhophylac (Rh0(D) immune globulin intravenous (human)) FDA Approval History

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.

• Erbitux ImClone - Treatment for Advanced Colorectal Cancer

Erbitux (cetuximab) FDA Approval History

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.

• Avastin Approved for treatment for Metastatic Colorectal Cancer

Avastin (bevacizumab) FDA Approval History

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

Myfortic (mycophenolic acid) FDA Approval History

Avastin (bevacizumab)

New Indication Approved: October 11, 2006

• FDA Approves Avastin in Combination With Chemotherapy for First-Line Treatment of Most Common Type of Lung Cancer

Avastin (bevacizumab) FDA Approval History

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

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

• FDA Approves Rhophylac for the Treatment of Immune Thrombocytopenic Purpura (ITP)

Rhophylac (Rh0(D) immune globulin intravenous (human)) FDA Approval History

Avastin (bevacizumab)

New Indication Approved: February 22, 2008

• FDA Grants Accelerated Approval of Avastin in Combination With Paclitaxel Chemotherapy for First-Line Treatment of Advanced HER2-Negative Breast Cancer

Avastin (bevacizumab) FDA Approval History

Alimta (pemetrexed)

New Indication Approved: September 26, 2008

• FDA Grants Lilly's Alimta (Pemetrexed for Injection) Third U.S. Approval

Alimta (pemetrexed) FDA Approval History

Avastin (bevacizumab)

New Indication Approved: May 5, 2009

• FDA Grants Accelerated Approval of Avastin for Brain Cancer (Glioblastoma) That Has Progressed Following Prior Therapy

Avastin (bevacizumab) FDA Approval History

Alimta (pemetrexed)

New Indication Approved: July 2, 2009

• Lilly Receives Fourth FDA Approval for Alimta (pemetrexed for injection) as Maintenance Therapy For Nonsquamous Non-Small Cell Lung Cancer

Alimta (pemetrexed) FDA Approval History

Avastin (bevacizumab)

New Indication Approved: July 31, 2009

• FDA Approves Avastin for the Most Common Type of Kidney Cancer

Avastin (bevacizumab) FDA Approval History

Erbitux (cetuximab)

New Indication Approved: November 7, 2011

• FDA Approves Erbitux to Treat Late-stage Head and Neck Cancer

Erbitux (cetuximab) FDA Approval History

Avastin (bevacizumab)

Labeling Revision Approved: November 18, 2011

• FDA Revokes Breast Cancer Indication for Avastin (bevacizumab)

Avastin (bevacizumab) FDA Approval History

Avastin (bevacizumab)

New Indication Approved: August 14, 2014

• FDA Approves Avastin for Metastatic Cervical Cancer

Avastin (bevacizumab) FDA Approval History

Avastin (bevacizumab)

New Indication Approved: November 14, 2014

• FDA Approves Avastin (bevacizumab) Plus Chemotherapy for Platinum-Resistant Recurrent Ovarian Cancer

Avastin (bevacizumab) FDA Approval History

Avastin (bevacizumab)

New Indication Approved: December 6, 2016

• FDA Approves Avastin (bevacizumab) Plus Chemotherapy for a Specific Type of Advanced Ovarian Cancer

Avastin (bevacizumab) FDA Approval History