New Drug Approvals Archive - September 2006

Noxafil (posaconazole)

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

Noxafil (posaconazole) FDA Approval History

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

Verdeso (desonide) FDA Approval History

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

Travatan Z (travoprost) FDA Approval History

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

Fentora (fentanyl) FDA Approval History

Vectibix (panitumumab) Injection

Date of Approval: September 27, 2006
Company: Amgen
Treatment for: Colorectal Cancer

Vectibix (panitumumab) is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS) metastatic colorectal cancer.

• FDA Approves Vectibix (panitumumab) to Treat Patients with Metastatic Colorectal Cancer

Vectibix (panitumumab) FDA Approval History

Pylera (bismuth subcitrate potassium, metronidazole and tetracycline) Capsules - formerly Helizide

Date of Approval: September 28, 2006
Company: Allergan, 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

Pylera (bismuth subcitrate potassium, metronidazole and tetracycline) FDA Approval History

Noxafil (posaconazole)

New Dosage Form Approved: November 25, 2013

• FDA Approves Merck’s Noxafil Delayed-Release Tablets

Noxafil (posaconazole) FDA Approval History

Noxafil (posaconazole)

New Dosage Form Approved: March 13, 2014

• FDA Approves Merck’s Noxafil (posaconazole) Injection

Noxafil (posaconazole) FDA Approval History

Vectibix (panitumumab)

New Indication Approved: May 23, 2014

• FDA Approves First-Line Use of Vectibix (panitumumab) Plus FOLFOX for Patients with Wild-Type KRAS Metastatic Colorectal Cancer

Vectibix (panitumumab) FDA Approval History

Vectibix (panitumumab)

New Indication Approved: June 29, 2017

• FDA Approves Vectibix (panitumumab) for Use in Wild-Type RAS Metastatic Colorectal Cancer

Vectibix (panitumumab) FDA Approval History