Pfizer’s Cardura XL Clears FDA For Benign Prostatic Hyperplasia
This article was originally published in The Pink Sheet Daily
The extended-release formulation of doxazosin has a narrower indication than the immediate-release formulation but allows for less frequent dose titration. Both formulations are once-daily.
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Company moves to terminate a supply and distribution deal with Pfizer because the BPH agent failed to receive FDA approval by Dec. 31, 2004. Andrx is divesting its brand business to focus on its "core competencies" of controlled-release formulation development and distribution.
Pfizer will "respond promptly" to FDA's "approvable" letter for Cardura XL, marketing partner Andrx says.
The cardiologist panel calls for use of the congestive heart failure therapy to be "strictly limited" to patients that present with symptoms in the hospital setting. The expert panel also recommends that Scios "immediately undertake" a professional educational campaign about Natrecor's appropriate uses.