Bertek Apomorphine Clears FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Bertek Apokyn (apomorphine) clears FDA April 20 for subcutaneous injection to treat "off" episodes of Parkinson's disease
Bertek Apokyn (apomorphine) clears FDA April 20 for subcutaneous injection to treat "off" episodes of Parkinson's disease. The product was deemed "approvable" in July 2003. The NDA was filed Dec. 31, 2002 and was granted "fast track" and orphan drug status. Mylan's brand subsidiary Bertek will promote the product. - Tericke Blanchard |