Pharmaceutical company Croma Pharma has submitted its botulinum toxin drug file to the German Federal Institute for Drugs and Medical Devices (BfArM), for approval for the treatment of glabellar lines in the EU.
The company explains that the submission is based on two completed Phase III pivotal trials conducted with a total of 917 subjects in the EU and the US.
Keeli Wetton, sales business manager at Croma UK, said, “Croma Pharma UK are delighted with the news that our new toxin is one step closer to obtaining its license for use across Europe. With excellent efficacy results in the preliminary clinical trials, we are very much looking forward to bringing this product to market in 2021. We have a very experienced sales team who have all previously sold botulinum toxin and understand the needs of the healthcare professional very well.”