Drugs

Novel Drug Approvals for 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.

 

No.

Drug Name

Active Ingredient

Date

FDA-approved use on approval date

41. Opdivo nivolumab 12/22/2014

To treat patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs
Press Release

40. Rapivab peramivir 12/19/2014 To treat influenza infection in adults
Press Release
39. Zerbaxa ceftolozane/tazobactam 12/19/2014

To treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI)
Press Release

38. (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) 12/19/2014 To treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis
Press Release
37. Lynparza olaparib 12/19/2014 To treat advanced ovarian cancer
Press Release
36. Xtoro finafloxacin otic suspension 12/17/2014 To treat acute otitis externa, commonly known as swimmer’s ear
Press Release
35. Blincyto blinatumomab 12/3/2014 To treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL)
Press Release
34. Esbriet pirfenidone 10/15/2014 For the treatment of idiopathic pulmonary fibrosis (IPF)
Press Release
33. Ofev nintedanib 10/15/2014 For the treatment of idiopathic pulmonary fibrosis (IPF)
Press Release
32. Lumason sulfur hexafluoride lipid microsphere 10/10/2014 For patients whose ultrasound image of the heart (echocardiograms) are hard to see with ultrasound waves
Press Release
31. Akynzeo netupitant and palonosetron 10/10/2014 To treat nausea and vomiting in patients undergoing cancer chemotherapy
Press Release
30. Harvoni ledipasvir/sofosbuvir 10/10/2014 To treat chronic hepatitis C virus (HCV) genotype 1 infection
Press Release
29. Trulicity dulaglutide 9/18/2014 To treat adults with type 2 diabetes.
Press Release
28. Movantik naloxegol 9/16/2014 To treat opioid-induced constipation in adults with chronic non-cancer pain.
Press Release 
27. Keytruda pembrolizumab 9/4/2014 For treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.
Press Release
26. Cerdelga eliglustat 8/19/2014 For the long-term treatment of adult patients with the Type 1 form of Gaucher disease
Press Release
25. Plegridy peginterferon beta-1a 8/15/2014 For the treatment of patients with relapsing forms of multiple sclerosis
24. Belsomra suvorexant 8/13/2014 To treat difficulty in falling and staying asleep (insomnia)
Press Release
23. Orbactiv oritavancin 8/6/2014 To treat adults with skin infections
Press Release
22. Jardiance empagliflozin 8/1/2104 To improve gylcemic control in adults with type 2 diabetes
Press Release  
21.

Striverdi Respimat

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

Sivextro (tablet)

Sivextro (injection)

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

Zontivity
 

vorapaxar 5/8/2014 To reduce the risk of heart attacks and stroke in high-risk patients
Press Release
12.

Zykadia

ceritinib 4/29/2014 To treat patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC)
Press Release
11.

Sylvant

siltuximab 4/23/2014 To treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes)
Press Release
10.

Cyramza

ramucirumab 4/21/2014 To treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma
Press Release
9.

Tanzeum

albiglutide 4/15/2014 To improve glycemic control, along with diet and exercise, in adults with type 2 diabetes
Press Release
8.

Otezla

apremilast 3/21/2014 To treat adults with active psoriatic arthritis (PsA)
Press Release
7.

Impavido

miltefosine 3/19/2014 To treat a tropical disease called leishmaniasis
Press Release
6.

Neuraceq

florbetaben F 18 injection 3/19/2014
For Positron EmissionTomography (PET) imaging of the brain
5.

Myalept

metreleptin for injection 2/24/2014 To treat the complications of leptin deficiency
Press Release
4.

Northera

droxidopa 2/18/2014 To treat neurogenic orthostatic hypotension (NOH)
Press Release
3 Vimizim elosulfase alfa 2/14/2014

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

2. Hetlioz tasimelteon 1/31/2014

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

 

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