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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

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 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 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 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 (biskalcitrate potassium, metronidazole and tetracycline) Capsules - formerly Helizide

Date of Approval: September 28, 2006

Company: Axcan Pharma Inc.

Treatment for Helicobacter pylori Infection

Pylera 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
 

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