Orphan Drugs: FDA PDUFA Dates January – February 2014
Investors and traders will be watching several orphan drug FDA PDUFA dates in January and February 2014.
FDA PDUFA Dates January – February 2014
|Generic Name||Trade Name||Sponsor||Indication||2014 PDUFA Date|
|Tasimelteon||Hetlioz||Vanda Pharmaceuticals||Non-24 Hour Sleep/Wake Disorder in Blind Individuals Without Light Perception||01/31|
|Droxidopa *||Northera||Chelsea Therapeutics||Symptomatic Neurogenic Orthostatic Hypotension For Patients With Primary Autonomic Failure||02/14|
|Elosulfase Alfa **||Vimizim||BioMarin Pharmaceutical||Mucopolysaccharidosis Type IV A (Morquio A Syndrome)||02/28|
|Ibrutinib||Imbruvica||Pharmacyclics||Chronic/Small-Cell Lymphocytic Leukemia||2/28|
** Priority Review
Please note the links for the following 2 chart columns above :
1) “Generic Name” Column Link = Is a source for the FDA PDUFA Date
2) “Indication” Column Link = Is the FDA Orphan Drug Product Designation Database Link.
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