Berlex' Angeliq Is "Approvable"; More Manufacturing Data Needed
This article was originally published in The Pink Sheet Daily
Executive Summary
The company anticipates a 2005 approval for the hormone replacement therapy for the lowest dose submitted. The firm is also touting a potential antihypertensive effect with Angeliq for higher doses.
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Berlex' Angeliq Approved, Will Launch In Mid-2006
The hormone therapy launch will be delayed to allow for physician education and to give the company time to consider internal resource issues as well as near-term pipeline opportunities, Berlex said.
Berlex' Angeliq Approved, Will Launch In Mid-2006
The hormone therapy launch will be delayed to allow for physician education and to give the company time to consider internal resource issues as well as near-term pipeline opportunities, Berlex said.
Angeliq Hormone Therapy Action Date Expected In Fourth Quarter
A late 2005 approval would come nearly four years after Schering AG filed the Angeliq NDA. Expected fourth quarter action date indicates company will submit CMC data by June.