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Msg  215616 of 226566  at  1/18/2018 3:09:43 PM  by

zippypie


CELG Celgene granted orphan drug designation by the FDA for Otezla for the treatment of pediatric patients with ulcerative colitis (101.38 -0.64)

 

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Generic Name: apremilast
Trade Name: Otezla®
Date Designated: 01/17/2018
Orphan Designation: Treatment of pediatric patients with ulcerative colitis
Orphan Designation Status: Designated
FDA Orphan Approval Status:Not FDA Approved for Orphan Indication
Marketing Approval Date: N/A
Approved Labeled Indication:
Exclusivity End Date: N/A
Celgene Corporation
86 Morris Avenue
Summit, New Jersey 07901
USA

The sponsor address listed is the last reported by the sponsor to OOPD.
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Msg # Subject Author Recs Date Posted
215635 Re: CELG Celgene granted orphan drug designation by the FDA for Otezla for the treatment of pediatric patients with ulcerative colitis (101.38 -0.64) Doolen 3 1/19/2018 9:45:33 AM




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