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.

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