New Molecular Entities Approved In 2014
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Annual listing of novel drugs cleared by FDA’s Center for Drug Evaluation and Research.
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Product And Sponsor |
Indication |
Date Approved (Application Number) |
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Farxiga Dapagliflozin Bristol-Myers Squibb/AstraZeneca |
Sodium-glucose cotransporter-2 (SGLT-2) inhibitor as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus |
1/8/2014 (202-293) (S) |
|
Hetlioz Tasimelteon Vanda Pharmaceuticals |
Melatonin receptor agonist for treatment of non-24-hour sleep-wake disorder in blind patients without light perception |
1/31/2014 (205-677) (P) |
|
Northera Droxidopa Chelsea Therapeutics |
Synthetic precursor of norepinephrine for treatment of orthostatic dizziness, lightheadedness or the “feeling that you are about to black out” in adults with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine beta-hydroxylase deficiency and nondiabetic autonomic neuropathy |
2/18/2014 (203-202) (P, H, V) |
|
Neuraceq Florbetaben F 18 Piramal Imaging SA |
Radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline |
3/19/2014 (204-677) (S) |
|
Impavido Miltefosine Paladin Therapeutics Inc. |
Antileishmanial drug for treatment of adults and adolescents aged 12 years and older who weigh at least 30 kg with visceral leishmaniasis due to Leishmania donovani; cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis and Leishmania panamensis; and mucosal leishmaniasis due to Leishmania braziliensis |
3/19/2014 (204-684) (P, V) |
|
Otezla Apremilast Celgene Corporation |
Phosphodiesterase 4 inhibitor for treatment of adults with active psoriatic arthritis |
3/21/2014 (205-437) (S) |
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S: Standard review P: Priority review V: Orphan drug H: Accelerated approval B: Breakthrough Therapy |
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