FDA grants orphan drug status to Diazepam Buccal soluble film
Release Date: 09-Dec-2016
MonoSol Rx, a leading pharmaceutical company has announced that U.S Food and Drug Administration (FDA) have granted orphan drug designation to Diazepam Buccal soluble film to treat acute retentive seizures. The agency is planning to initiate a pivotal study of diazepam BSF in adults in early 2017.
Orphan Drug designation is granted to those medications or therapy that are rare, more specifically, affect less than 200,000 patients in the country. These rare diseases are incurable and severe in nature and may cause death. To fulfill the need of treat options for individuals, FDA grants orphan drug designation to drugs which are investigated to be helpful in the treatment of such rare diseases. Orphan drug status is a package of several financial benefits for the drugs and its manufacturers such as certain tax credits and exemption from paying prescription drug user fees normally required from companies submitting products for approval.
For Orphan Drug Clinical Insight Reports Contact: email@example.com
Need custom market research solution? We can help you with that too.
Kuick Research is a market research and analytics company that provides targeted information for critical decisions at business, product and
service levels. We are quick, predictive and known by the recommendations we have made in the past. Our result-oriented research methodology offers
understanding of multiple issues in a short period of time and gives us the capability to keep you full with loads of practical ideas.