New Drug Approvals Archive
New Drug Approvals: September 2006
| September 15 | Noxafil (posaconazole) Oral Suspension Date of Approval: September 15, 2006 Company: Schering-Plough Corporation Treatment for: Aspergillosis -- Invasive, Candidemia, Oral Thrush Noxafil is a triazole antifungal agent indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. Noxafil Schering-Plough Corporation - Treatment for Prevention of Invasive Fungal Infections |
| September 19 | Verdeso (desonide) Foam Date of Approval: September 19, 2006 Company: Connetics Corporation Treatment for: Dermatitis Verdeso (desonide) Foam is a low-potency topical steroid formulated in VersaFoam emulsion foam drug delivery vehicle for the treatment of mild-to-moderate atopic dermatitis. Verdeso Connetics Corporation - Treatment for Mild-to-Moderate Atopic Dermatitis |
| September 21 | Travatan Z (travoprost) Ophthalmic Solution Date of Approval: September 21, 2006 Company: Alcon, Inc. Treatment for: Glaucoma Travatan Z (travoprost) is a new formulation of Travatan solution in which benzalkonium chloride is replaced with Sofzia, a robust ionic buffered preservative system that is gentle to the ocular surface. Travatan Z is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, who are intolerant of or insufficiently responsive to other intraocular pressure lowering medications. Travatan Z Alcon, Inc. - Treatment for Glaucoma and Ocular Hypertension |
| September 25 | Fentora (fentanyl) Buccal Tablets - formerly OraVescent Fentanyl Date of Approval: September 25, 2006 Company: Cephalon, Inc. Treatment for: Pain Fentora is an effervescent buccal formulation of the potent opioid analgesic fentanyl, indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Fentora Cephalon, Inc. - Treatment for Breakthrough Pain in Patients with Cancer |
| September 27 | Vectibix (panitumumab) Injection Date of Approval: September 27, 2006 Company: Amgen Treatment for: Colorectal Cancer Vectibix (panitumumab) is a recombinant, human IgG2 kappa monoclonal antibody indicated for the treatment of patients with epidermal growth factor receptor- (EGFr) expressing metastatic colorectal cancer after disease progression on, or following fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens. Vectibix Amgen - Treatment for Metastatic Colorectal Cancer |
| September 28 | Pylera (bismuth subcitrate potassium, metronidazole and tetracycline) Capsules - formerly Helizide Date of Approval: September 28, 2006 Company: Axcan Pharma Inc. Treatment for: Helicobacter pylori Infection Pylera (bismuth subcitrate potassium, metronidazole and tetracycline) is a 3-in-1 capsule triple therapy indicated for the eradication of Helicobacter pylori, a bacterium now recognized as being the main cause of gastric and duodenal ulcers. Pylera Axcan Pharma Inc. - Treatment for Eradication of Helicobacter pylori |
New Drug Approvals Archive
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