In the news: Doubt over Azilect(R) relabeling.

摘要

Advisors-to the Food-and Drug Administration (FDA) have expressed skepticism over the relabeling of Azilect~R (Teva Pharmaceutical Industries Ltd [TEVA], Petah Tikva, Israel)-a formulation of rasagiline, which is already approved for the treatment of the symptoms of Parkinson disease (PD)-as a drug that can alter the progression of disease.In the first case of its kind, TEVA applied for the reclassification of Azilect~R, claiming that it could slow the progression of PD. TEVA presented data showing that treatment of patients with 1 mg doses of Azilect~R improved the symptoms of PD and slowed disease progression compared with placebo. However, no effect on disease progression was seen in patients who received 2 mg doses of Azilect~R."If you tell people in labeling that a drug has an effect on disease progression, you want to be sure that it does indeed have an effect on disease progression," Russell Katz, Head of the FDA's Division of Neurology Products, was quoted to have told the advisors before their decision. "