Reports from the Field: New drug updates
FDA approves cervical dystonia treatment
Elan in Dublin, Ireland, received FDA approval for Myobloc (botulinum toxin type B) Injectable Solution for the symptomatic treatment of patients with cervical dystonia (CD) to reduce the severity of abnormal head position and neck pain associated with CD.
Myobloc works by interrupting the cholinergic transmission between the nerve and the affected muscle, causing the muscle to relax. As the first FDA-approved treatment for CD, Myobloc offers new hope for patients with this debilitating disease, says Mark Lew, MD, director of the division of movement disorders at the University of Southern California School of Medicine in Los Angeles and clinical trial investigator for Myobloc. "Cervical dystonia can be a painful, disabling, and sometimes embarrassing disease," says Lew. "The FDA approval is very exciting, important news for patients."
Full prescribing information is available by calling (888) 461-2255.
Drug melts blues away
Organon in West Orange, NJ, recently received FDA approval for REMERONSolTab, mirtazapine, orally disintegrating tablets, the first disintegrating antidepressant tablet. The REMERONSolTab dissolves on the tongue in 30 seconds with or without water. The manufacturer suggests that the easy delivery method may improve patient compliance with antidepressant therapy; it is the only antidepressant tablet that does not have to be swallowed whole.
In addition to its delivery method, the drug has a unique pharmacological profile that increases levels of both norepinephrine and serotonin in the brain to fight depression.
HCFA approves injectable iron treatment for anemia
Watson Pharmaceuticals in Corona, CA, recently announced two important decisions regarding Medicare reimbursement for its injectable iron product, Ferrlecit (sodium ferric gluconate complex in sucrose injection).
Medicare began reimbursing Ferrlecit as a first-line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoetin therapy as of Dec. 1, 2000. In addition, HCFA was assigned a Common Procedure Coding System code for Ferrlecit on Jan. 1. Ferrlecit has been assigned HPCS code J2915.
These two announcements give Ferrlecit a uniform coverage and billing procedure under Medicare.
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