Ranexa May Launch In 2006; CV Therapeutics And FDA Discussing New Study
This article was originally published in The Pink Sheet Daily
The company expects to obtain a special protocol assessment for the trial, which will likely focus on a restricted angina population. After approval, CVT expects to expand the label through additional studies.
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Refractory angina trial designed under a special protocol assessment with FDA will begin in the third quarter. The company predicts a "broad restricted label" based on the study, which follows recommendations made by FDA's Cardio-Renal Drugs Advisory Committee.
Amended application includes 50 mg and 100 mg dosage forms, which are used in multiple myeloma.