Drug Criteria & Outcomes: New FDA Approvals
Drug Criteria & Outcomes
New FDA Approvals
• Antiepileptic oral suspension oxcarbazepine (Trileptal) by Novartis Pharmaceuticals Corp. The Food and Drug Administration (FDA) has granted marketing clearance for an oral suspension formulation of Trileptal in the treatment of people with epilepsy who have difficulty taking tablets. Trileptal is available as a 300 mg/5 mL (60 mg/mL) oral suspension.
• Travoprost ophthalmic solution (Travatan) by Alcon Universal. Travatan has been approved by the FDA for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. It is indicated for patients who are intolerant of or insufficiently responsive to other intraocular pressure-lowering medications. The recommended dosage is one drop in the affected eye(s) once daily in the evening.
• Campath, a humanized monoclonal antibody, by Berlex Laboratories. The FDA has granted accelerated approval for Campath as an injectable treatment for B-cell chronic lymphocytic leukemia (B-CLL). Campath is designed for use in B-CLL patients who have been treated with alkylating agents and have failed fludarabine therapy.
• Albuterol sulfate inhalation aerosol (Ventolin HFA) by GlaxoSmithKline. The FDA has approved Ventolin HFA for the treatment or prevention of bronchospasm in adults and children four years of age and older with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm in patients four years of age and older. Ventolin HFA is a new version of the Ventolin metered-dose inhaler (MDI) currently marketed by GlaxoSmithKline. Unlike the current version, however, the new inhaler does not use chlorofluorocarbons (CFCs) to propel the medication. Ventolin HFA uses an alternative propellant called HFA or hydrofluoroalkane.
• Azelaic acid cream 20% (Finevin) by Berlex Laboratories. The FDA has approved the marketing of Finevin for the topical treatment of mild to moderate inflammatory acne vulgaris. Finevin should be applied twice a day, in the morning and evening. A majority of patients with inflammatory lesions may experience an improvement in their acne within four weeks of beginning treatment. However, treatment may be continued over several months, if necessary.
• Calcium acetate (PhosLo) capsules and gelcaps by Braintree Laboratories. PhosLo has been approved for the control of hyperphosphatemia in end-stage renal failure in adult patients. Excessive dosage of PhosLo induces hypercalcemia; therefore, early in the treatment during dosage adjustment serum calcium should be determined twice weekly. The serum calcium times phosphate (CaXP) product should not be allowed to exceed 66.
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