FDA approves SD-809 for orphan drug designation

The US food and drug Administration (FDA) has granted orphan drug status SD-809.

Release Date: 05-Dec-2016



The US food and drug Administration (FDA) has granted orphan drug status SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington disease (HD). The compound is being developed by an Israeli drug manufacturer, Teva Pharmaceutical Industries (NYSE: TEVA). The drug is also being tested for the treatment of tardive dyskinesia (TD) and Tourette syndrome (TS).

 

The FDA Orphan Drug Designation is granted to medicines and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment medicine.

 

 

For Orphan Drug Clinical Insight Reports Contact:   neeraj@kuickresearch.com

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