FDA rejects Actavis' contraceptive patch, asks for more data
Dec 24 (Reuters) - Actavis Plc said the U.S. Food and Drug Administration denied approval to its contraceptive patch and asked for more data.
The FDA questioned the differences in size/formulation between the patch used in trial and the to-be-marketed patch, in a "complete response letter" to Actavis.
Such letters typically lay out FDA concerns that need to be addressed before a treatment can gain approval.
Actavis said it planned to work closely with the FDA to address the questions.
The patch for women, to be used by placing on the skin, is designed to provide continuous delivery of the hormone norethindrone during a once-weekly, seven-day dosing regimen.