Actavis contraceptive patch doesn't win FDA approval
DUBLIN — The Food and Drug Administration declined to approve an experimental contraceptive patch developed by Actavis, the drug maker said Tuesday.
Actavis said the FDA sent it a complete response letter for its progestin-only transdermal contraceptive patch. A complete response letter means that the agency has finished reviewing a drug-approval application, but questions remain that preclude final approval.
The FDA is requesting more data on the difference between the patch used in the clinical trial and the one Actavis intends to market, which is a different size and formulation, the company said.