FDA Approval for oral contraceptive – teamwork to success
SCOPE International AG announces that The US Food and Drug Administration (FDA) has approved the new drug application (NDA) of an oral contraceptive for pregnancy prevention that was developed by one of our clients. SCOPE played a major role throughout the developmental process. The entirety of this endeavor involved 10 years of collaboration with the sponsor over 8 projects using 250 clinical sites where 5000 subjects were enrolled. SCOPE conducted dose finding studies, multiple phase II trials, and the phase III program in both Europe and the US.
“We are happy and delighted to hear that this product achieved marketing authorization.”Having worked with the sponsor throughout the entirety of the clinical development process starting with dose finding and culminating with the pivotal phase III program in Europe and US, we are extremely proud of our major contributions that led to the approval. It is a very promising product and we can expect a high market impact.“
– said Michael Binder, Director Operation Women’s Health.
The relationship that was formed with the sponsor throughout this journey was a key element to the successful market approval. SCOPE aims to provide individualized attention to all clients and takes pride in our collaborative and flexible approach. Communicating with the sponsor through each step of the clinical process and collaborating on important issues led to optimal decision making.
Client repeat business is the best testimony to the strength of our relationships. We will now build on our already strong partnership that led to this market approval as we focus our attention on a clinical development program for a new product in this client‘s pipeline. As always, we are honored to be a part of the process.