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.
|
Product And Sponsor |
Indication |
Date Approved (Application Number) |
|
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) |
|
S: Standard review P: Priority review V: Orphan drug H: Accelerated approval B: Breakthrough Therapy |
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