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U.S. Department of Health and Human Services

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New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products of 2014

Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, FDA provides scientific and regulatory advice needed to bring new therapies to market. The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development. 

Each year, CDER approves a wide range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.

Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.

 

Graph symbol View animated charts from the 2013 Novel New Drugs Summary publication on the right. (Not viewable in Internet Explorer version 7 and below.)

Link to the 2013 Novel New Drugs Summary (PDF - 3MB)

2013 Novel New Drugs Summary (PDF - 3MB)

 


The list below includes the NMEs and BLAs approved by CDER in calendar year 2014.

(The Drug Name link provides full product details, i.e., prescribing information, approval history, and reviews.)


No.

Drug Name

Active Ingredient

Date

What It’s Used For

34.Esbrietpirfenidone10/15/2014For the treatment of idiopathic pulmonary fibrosis (IPF)
Press Release
33.Ofevnintedanib10/15/2014For the treatment of idiopathic pulmonary fibrosis (IPF)
Press Release
32.Lumasonsulfur hexafluoride lipid microsphere10/10/2014For patients whose ultrasound image of the heart (echocardiograms) are hard to see with ultrasound waves
Press Release
31.Akynzeonetupitant and palonosetron10/10/2014To treat nausea and vomiting in patients undergoing cancer chemotherapy
Press Release
30.Harvoniledipasvir/sofosbuvir10/10/2014To treat chronic hepatitis C virus (HCV) genotype 1 infection
Press Release
29.Trulicitydulaglutide9/18/2014To treat adults with type 2 diabetes.
Press Release
28.Movantiknaloxegol9/16/2014To treat opioid-induced constipation in adults with chronic non-cancer pain.
Press Release 
27.Keytrudapembrolizumab9/4/2014For treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.
Press Release
26.Cerdelgaeliglustat8/19/2014For the long-term treatment of adult patients with the Type 1 form of Gaucher disease
Press Release
25.Plegridypeginterferon beta-1a8/15/2014For the treatment of patients with relapsing forms of multiple sclerosis
24.Belsomrasuvorexant8/13/2014To treat difficulty in falling and staying asleep (insomnia)
Press Release
23.Orbactivoritavancin8/6/2014To treat adults with skin infections
Press Release
22.Jardianceempagliflozin8/1/2104To improve gylcemic control in adults with type 2 diabetes
Press Release  
21.

Striverdi Respimat

olodaterol7/31/2014To treat chronic obstructive pulmonary disease
Press Release 
20.
 
Zydeligidelalisib7/23/2014To treat patients with trhee types of blood cancers
Press Release 
19.Kerydin
 
tavaborole7/7/2014For the topical treatment of onychomycosis of the toenails
(No Press Release)
18.Beleodaqbelinostat7/3/2014To treat patients with peripheral T-cell lymphoma (PTCL)
Press Release
17.

Sivextro (tablet)

Sivextro (injection)

tedizolid phosphate6/20/2014To treat adults with skin infections
Press Release
16.Jublia
 
efinaconazole6/6/2014
Treat mild to moderate onychomycosis (fungal infection)
 No Press Release
15.Dalvance
 
dalbavancin 5/23/2014To treat adults with skin infections
Press Release 
14.Entyvio
 
vedolizumab5/20/2014To treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease
Press Release
13.

Zontivity
 

vorapaxar5/8/2014To reduce the risk of heart attacks and stroke in high-risk patients
Press Release
12.

Zykadia

ceritinib4/29/2014To treat patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC)
Press Release
11.

Sylvant

siltuximab4/23/2014To treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes)
Press Release
10.

Cyramza

ramucirumab4/21/2014To treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma
Press Release
9.

 Tanzeum

albiglutide4/15/2014To improve glycemic control, along with diet and exercise, in adults with type 2 diabetes
Press Release
8.

Otezla

apremilast3/21/2014To treat adults with active psoriatic arthritis (PsA)
Press Release
7.

Impavido

miltefosine3/19/2014To treat a tropical disease called leishmaniasis
Press Release
6.

Neuraceq

florbetaben F 18 injection3/19/2014
For Positron EmissionTomography (PET) imaging of the brain
5.

Myalept

metreleptin for injection2/24/2014To treat the complications of leptin deficiency
Press Release
4.

Northera

droxidopa2/18/2014To treat neurogenic orthostatic hypotension (NOH)
Press Release
3.Vimizimelosulfase alfa2/14/2014

Treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome)
Press Release

2.Hetlioztasimelteon1/31/2014

To treat non-24- hour sleep-wake disorder (“non-24”) in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep.

Press Release

1.Farxigadapaglifozin1/8/2014To improve glycemic control, along with diet and exercise, in adults with type 2 diabetes
Press Release

 

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