FDA rejects Actavis' contraceptive patch, seeks more data

(Reuters) - Actavis Plc said U.S. health regulators denied approval to its contraceptive patch for women and asked for more data. The U.S. Food and Drug Administration questioned the differences in size and formulation of the patch used in trials and the to-be-marketed patch. The generic drugs maker, which received a "complete response letter" from the FDA, said it planned to work closely with the agency to address the questions. Such letters typically lay out FDA concerns that need to be addressed before a treatment is approved.



via Health News Headlines - Yahoo News http://news.yahoo.com/fda-rejects-actavis-39-contraceptive-patch-seeks-more-145636155--finance.html