Bertek Pharmaceuticals, Subsidiary Of Mylan Laboratories Inc. (MYL) , Receives FDA Approval For Parkinson’s Disease Treatment (Previously Announced)
10/19/2005 5:11:17 PM
Britannia Pharmaceuticals Limited announced today that U.S.-based Bertek Pharmaceuticals Inc., the branded subsidiary of Mylan Laboratories Inc has received approval from the Food and Drug Administration for APOKYN (apomorphine hydrochloride injection). APOKYN is approved for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) associated with advanced Parkinson's disease. Britannia licensed the injectable apomorphine hydrochloride formulation to Bertek in 1999. Under the terms of the companies’ agreement, Bertek licensed the rights to apomorphine and assumed control of all regulatory and marketing initiatives as well as the commercialization of the product in the United States.