New Drug Approvals Archive
New Drug Approvals: October 2007
| October 1 | FDA Approves Symlin Pen-Injector Devices Offering Convenience and Accuracy for Symlin Use |
| October 1 | Taxotere (docetaxel) Granted FDA Approval to Treat Locally Advanced Head and Neck Cancer Prior to Chemoradiotherapy and Surgery |
| October 1 | FDA Approves Lamisil for Pediatric Treatment of Scalp Ringworm |
| October 3 | Survival Data in FDA Approval for Erbitux (Cetuximab) Supports Use as a Single Agent in Patients with Advanced Colorectal Cancer |
| October 5 | Aptivus (tipranavir) Capsules Granted Full Approval by the U.S. FDA |
| October 12 | Isentress (raltegravir) Tablets Date of Approval: October 12, 2007 Company: Merck & Co., Inc. Treatment for HIV Infection Isentress is an integrase inhibitor indicated for the treatment of Human Immunodeficiency Virus (HIV)-1 infection in combination with other antiretroviral agents. FDA Approves of Isentress (raltegravir) |
| October 15 | FDA Approves Administration of Lexiva with Lower Dose of 'Boosting' Medication Ritonavir |
| October 15 | GSK Receives Approval for Hycamtin (topotecan) Capsules for the Treatment of Relapsed Small Cell Lung Cancer |
| October 15 | FDA Expands Velcade (Bortezomib) for Injection Label for Patients with Multiple Myeloma |
| October 15 | Doribax (doripenem) Injection - formerly Doripenem Date of Approval: October 12, 2007 Company: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Treatment for Intraabdominal Infection, Urinary Tract Infection Doribax is a penem antibacterial indicated for the treatment of complicated intra-abdominal and complicated urinary tract infections, including pyelonephritis. FDA Approves Doribax for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract Infections |
| October 17 | Ixempra (ixabepilone) Injection Date of Approval: October 16, 2007 Company: Bristol-Myers Squibb Treatment for Breast Cancer Ixempra (ixabepilone) is a semisynthetic analog of epothilone B indicated for the treatment of patients with metastatic or locally advanced breast cancer. FDA Approves Ixempra (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer |
| October 17 | FDA Approves Supplemental New Drug Applications for Januvia (sitagliptin) |
| October 18 | FDA Expands Age Range for Use of Menactra Bacterial Meningitis Vaccine |
| October 22 | Voltaren Gel (diclofenac sodium) Topical Gel Date of Approval: October 17, 2007 Company: Novartis AG Treatment for Osteoarthritis Voltaren Gel (diclofenac sodium) is a topical gel non-steroidal anti-inflammatory (NSAID) medication indicated for the pain of osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands. Voltaren Gel Receives US Regulatory Approval as the First Approved Topical Prescription Treatment for Pain Associated with Osteoarthritis |
| October 22 | Renvela (sevelamer carbonate) Tablets Date of Approval: October 19, 2007 Company: Genzyme Corporation Treatment for Hyperphosphatemia of Renal Failure Renvela (sevelamer carbonate) is a calcium-free, metal-free, non-absorbed phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. FDA Approves Genzyme's Renvela for Dialysis Patients |
| October 29 | Tasigna (nilotinib) Capsules Date of Approval: October 29, 2007 Company: Novartis Treatment for Chronic Myelogenous Leukemia Tasigna is a kinase inhibitor indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included imatinib. Tasigna Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients with Resistance or Intolerance to Existing Therapies |
| October 31 | Combigan (brimonidine tartrate and timolol maleate) Ophthalmic Solution Date of Approval: October 30, 2007 Company: Allergan Inc. Treatment for Intraocular Hypertension, Glaucoma Combigan is an alpha adrenergic receptor agonist and beta adrenergic receptor inhibitor combination ophthalmic solution for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. Allergan, Inc. Receives FDA Approval for Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% |
New Drug Approvals Archive
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