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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.
