New Drug Approvals Archive - September 2006
Date of Approval: September 15, 2006
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.
Verdeso (desonide) Foam
Date of Approval: September 19, 2006
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.
Travatan Z (travoprost) Ophthalmic Solution
Date of Approval: September 21, 2006
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.
Fentora (fentanyl) Buccal Tablets - formerly OraVescent Fentanyl
Date of Approval: September 25, 2006
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.
Vectibix (panitumumab) Injection
Date of Approval: September 27, 2006
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.
Pylera (bismuth subcitrate potassium, metronidazole and tetracycline) Capsules - formerly Helizide
Date of Approval: September 28, 2006
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.
New Dosage Form Approved: November 25, 2013
New Dosage Form Approved: March 13, 2014