Dec 24 2013
Actavis plc (NYSE: ACT) today confirmed that the Company's subsidiary has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for a progestin-only transdermal contraceptive patch (Norethindrone Transdermal Delivery System) for use by women to prevent pregnancy.
The Company stated that it intends to work closely with the FDA to address the items raised in the complete response letter which primarily related to questions regarding the difference between the transdermal patch used in the clinical trial and the to-be-marketed transdermal patch, which represents a different size/formulation.
Data submitted to the FDA in support of approval of NDA for progestin-only patch included results from a 12-month, multicenter, open-label clinical trial conducted in the U.S., in accordance with FDA guidance for a contraceptive study. Actavis submitted the NDA to the FDA on February 26, 2013.
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