FDA's NDA And BLA Approvals: Austedo
Executive Summary
Original new drugs and biologics recently approved by US FDA.
Below are FDA's original approvals of NDAs and BLAs issued in the past week. Please see key below chart for a guide to frequently used abbreviations.
|
Sponsor |
Product |
Indication |
Code |
Approval Date |
|
New Drugs |
||||
|
Teva |
Austedo (deutetrabenazine) |
Treatment of chorea associated with Huntington’s disease |
S, 1 |
4/3/2017 |
|
Key To Abbreviations |
|
Review Classification |
|
P: Priority review; S: Standard review; O: Orphan Drug |
|
NDA Chemical Types |
|
1: New molecular entity (NME); 2: New active ingredient; 3: New dosage form; 4: New Combination 5: New formulation or new manufacturer; 6: New indication; 7: Drug already marketed without an approved NDA; 8: OTC (over-the-counter) switch; 9: New indication submitted as distinct NDA – consolidated with original NDA; 10: New indication submitted as distinct NDA - not consolidated with original NDA |