Food & Drug Law Weekly
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Food & Drug Law Weekly
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Biotechnology Business
Cephalon Notified of Generic Filing for Armodafinil Tablets
November 6th, 2009
Cephalon, Inc. (NASDAQ: CEPH) announced receipt of a Paragraph IV Certification Notice Letter on October 20, 2009 regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Teva Pharmaceuticals USA, Inc. requesting approval to market and sell a generic version of the 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths of NUVIGIL=AE (armodafinil) Tablets [C-IV]. In the Notice Letter, Teva alleges that U.S. Patent Nos. 7,132,570 (the "'570 Patent"), 7,297,346 (the "'346 Patent") and RE37,516 (the "'516 Patent") issued to Cephalon are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product...
Source: Food & Drug Law Weekly (2009-11-06)
|
