Mar 28, 2002 /PRNewswire-FirstCall via COMTEX/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI chart, msgs), announced today that it received a "not approvable" letter from the U.S. Food and Drug Administration (FDA) for Oxytrol(TM) (oxybutynin transdermal system), the Company's transdermal oxybutynin therapy for which they are seeking an indication for the treatment of overactive bladder with symptoms of urge incontinence, urgency and frequency.
The FDA is requesting additional clinical data. The Company has available additional data from the recently completed Phase IIIb trial, which has not been reviewed by the FDA. The Company believes this data may be sufficient to satisfy the FDA's concerns.
"Watson is committed to working with the FDA to reach resolution of the issues raised in the letter in a prompt manner," said Allen Chao, Ph.D., Chairman and Chief Executive Officer of Watson. "While this is disappointing, we firmly believe that we can address the FDA's issues and gain approval of this product."
Watson also announced today that, as a result of the delay in approval for Oxytrol(TM), it is revising its financial outlook for fiscal 2002. While the Company does not expect to have revenues from Oxytrol(TM) in 2002, significant launch expenses will also be postponed. The Company currently expects 2002 revenues to range from $1.20 to $1.25 billion. Estimates for diluted cash earnings per share are expected to increase to approximately $1.86 to $1.96 per share. Estimates for diluted GAAP earnings per share (EPS) are expected to increase to approximately $1.60 to $1.70 for 2002. |
