ARTICLE | Company News
FDA denies Watson's formal dispute resolution request
October 27, 2012 1:08 AM UTC
Watson Pharmaceuticals Inc. (NYSE:WPI) said FDA denied the company's request for a formal dispute resolution related to a February complete response letter for Prochieve vaginal progesterone gel. The company was seeking approval for Prochieve to prevent preterm birth in women with a short cervical length. Watson said it plans to "review possible options related to the continued pursuit of the NDA." Watson did not disclose details. ...