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Trimel Pharmaceuticals Corp Announces United States Food And Drug Administration Acceptance For CompleoTRT

Tuesday, 9 Jul 2013 08:11am EDT 

Trimel Pharmaceuticals Corp announced that the New Drug Application (NDA) for its bioadhesive intranasal gel testosterone product (CompleoTRT) has been formally accepted for review by the United States Food and Drug Administration (the FDA). The NDA is supported by efficacy and safety results from 306 patients who participated in the pivotal Phase III study. Additionally, the FDA has confirmed that under the United States Prescription Drug User Fee Act, the NDA will be subject to a standard review and the target action date for the NDA is February 28, 2014. 

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