New FDA Approvals
These drugs recently received final approval from the Food and Drug Administration (FDA):
Anesthetic sevoflurane (Ultane) by Abbott Laboratories. The FDA has granted approval of sevoflurane for the induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery.
Antiviral valganciclovir hydrochloride (Valcyte) tablets by Roche. The FDA has granted approval of valganciclovir for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). The drug is available in 450 mg tablets.
DuoNeb (3 mg albuterol sulfate and 0.5 mg ipratropium bromide per 3 mL) inhalation solution by Dey Laboratories. DuoNeb has been approved for the treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) in patients who require more than one bronchodilator.
Galantamine hydrobromide (Reminyl) by Janssen. The FDA has granted approval of galantamine for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine is dosed twice daily and is available in 4 mg, 8 mg, and 12 mg tablets.
In the Pipeline
AstraZeneca’s budesonide modified-release capsule (Entocort) has been granted priority review status by the FDA. The drug has been filed for the treatment of mild to moderate, active Crohn’s disease.
Eli Lilly reports that the FDA’s Center for Biologics Evaluation and Research has granted priority review to product drotrecogin alfa (proposed brand name: Zovant). The biologics license application was filed in January for the product to be used in the treatment of sepsis with associated acute organ dysfunction.
Inex Pharmaceuticals Corp. began enrolling patients in a Phase II trial for its lead product, Onco TCS, as part of a first-line treatment for aggressive non-Hodgkin’s lymphoma. The trial is being conducted at the University of Texas MD Anderson Cancer Center in Houston. Onco TCS also is being evaluated in a pivotal Phase II/III trial for second or later relapsed aggressive non-Hodgkin’s lymphoma and in two Phase II trials.
MGI Pharma Inc. reports commencing a pivotal Phase III trial of irofulven, its anticancer agent for treatment of patients with advanced-stage pancreatic cancer. The study compares irofulven to 5-fluorouracil (5-FU) with survival as the primary endpoint. Tumor response and other clinical benefits are the secondary endpoints.
NeoTherapeutics has started a Phase II study of Neotrofin in Parkinson’s disease. Neotrofin already has been administered to 1,100 patients for the treatment of Alzheimer’s disease.
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