Actavis Receives FDA Response Letter For Contraceptive Patch NDA

(RTTNews) - Actavis plc (ACT) confirmed that the company's subsidiary has received a complete response letter from the FDA for its New Drug Application for a progestin-only transdermal contraceptive patch for use by women to prevent pregnancy. Actavis submitted the NDA to the FDA on February 26, 2013.

The company said 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.