Chao, PhD, chairman and chief executive officer of Watson Pharmaceuticals, said, " Rhone-Poulenc Rorer's intent, through its successor, Aventis, to sell Cardizem CD, a product which competes with our Dilacor XR
product and its generic equivalent, violates Rhone-Poulenc Rorer's agreements with Watson.
Currently we have filed 11 ANDAs with the FDA, of which two are already on the market; Dilacor XR
and Cardizem CD generics, which we've trademarked and sell under the names Diltia XT and Cartia XT.
Additionally, the Company announced that it was writing off almost all of its investment in Dilacor XR
and that the Company was writing off over $20 million in additional impaired inventory.
These include the FDA's investigation into the company's Corona, CA manufacturing plant, the recall and launch delay of the company's Nicotine Gum product due to legal issues regarding product packaging as well as potential supply issues related to Dilacor XR
In addition to Adalat CC, we also have our generic versions of Cardizem CD, Procardia XL, Voltaren SR and Dilacor XR
awaiting FDA approval and expect to receive these approvals in due coarse.
The approval of our first Abbreviated New Drug Application for pentoxifylline and significant product filings with the Food and Drug Administration including generic versions of Procardia XL, Adalat CC, Voltaren XR and Dilacor XR
during 1998, confirms the Company's ability to meet strategic objectives and will allow the Company to significantly build upon our existing business.
The company also reported it had filed in the third quarter an Abbreviated New Drug Application (ANDA) for a generic version of Dilacor XR
, a once daily formulation of diltiazem which has U.