February Full Approvals
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Original approvals of NDAs and BLAs.
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Product and Sponsor |
Indication |
Date Approved (Application No.) |
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New Drugs |
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Imbruvica Ibrutinib Pharmacyclics Inc. 1P |
Kinase inhibitor for treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy |
2/12/2014 (205-552/original-2) (205-552/original-1 is the 11/13/2013 approval for mantle cell lymphoma) |
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Northera Droxidopa Chelsea Therapeutics Inc. 1P |
Synthetic amino acid precursor of norepinephrine for the treatment of orthostatic dizziness, lightheadedness or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypertension caused by primary autonomic failure (Parkinson’s disease multiple system atrophy, neuropathy and pure autonomic failure), dopamine beta-hydroxylase deficiency and non-diabetic autonomic neuropathy |
2/18/2014 (203-202) |
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Tivorbex Indomethacin Iroko Pharmaceuticals LLC 3 |
Non-steroidal anti-inflammatory drug in capsule formulation for treatment of mild to moderate acute pain in adults |
2/24/2014 (204-768) |
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New Biologics |
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Myalept Metreleptin Amylin Pharmaceuticals LLC |
Leptin analog for use as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy |
2/24/2014 (125390) |
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Vimizim Elosulfase alfa BioMarin Pharmaceutical Inc. |
Hydrolytic lysosomal glycosaminoglycan-specific enzyme replacement therapy for patients with mucopolysaccharidosis type IVA (Morquio A syndrome) |
2/14/2014 (125460) |
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P: Priority Review (drug represents therapeutic gain over existing therapies) S: Standard Review V: Orphan Drug H: Accelerated Approval (Subpart H)1: New molecular entity 2: New salt 3: New formulation 4: New combination 5: Already marketed in U.S. by another firm 6: Already marketed by same firm, usually a new indication 7: First NDA for already marketed drug |
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