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31 Dec 2014

NMEs and BLAs approved by USFDA in 2014

In 2014, 41 NMEs and BLAs approved by CDER in calendar year 2014 up from 27 in 2013.

 

new drugs40%

With almost 40 percent of the new drugs that were approved in the U.S. in 2014 for treating rare diseases, it’s not unusual for annual costs per patient to reach more than $100,000.


The list below includes the NMEs and BLAs approved by CDER in calendar year 2014.
NME – New Molecular EntityBLA – Biologics License Application

 

 

Sl. Drug Name Active Ingredient Date FDA-approved use on approval date
41 Opdivo nivolumab Monday, December 22, 2014 To treat patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs
40 Rapivab peramivir Friday, December 19, 2014 To treat influenza infection in adults
39 Zerbaxa ceftolozane/tazobactam Friday, December 19, 2014 To treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI)
38 Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) Friday, December 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
37 Lynparza olaparib Friday, December 19, 2014 To treat advanced ovarian cancer
36 Xtoro finafloxacin otic suspension Wednesday, December 17, 2014 To treat acute otitis externa, commonly known as swimmer’s ear
35 Blincyto blinatumomab Wednesday, December 03, 2014 To treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL)
34 Esbriet pirfenidone Wednesday, October 15, 2014 For the treatment of idiopathic pulmonary fibrosis (IPF)
33 Ofev nintedanib Wednesday, October 15, 2014 For the treatment of idiopathic pulmonary fibrosis (IPF)
32 Lumason sulfur hexafluoride lipid microsphere Friday, October 10, 2014 For patients whose ultrasound image of the heart (echocardiograms) are hard to see with ultrasound waves
31 Akynzeo netupitant and palonosetron Friday, October 10, 2014 To treat nausea and vomiting in patients undergoing cancer chemotherapy
30 Harvoni ledipasvir/sofosbuvir Friday, October 10, 2014 To treat chronic hepatitis C virus (HCV) genotype 1 infection
29 Trulicity dulaglutide Thursday, September 18, 2014 To treat adults with type 2 diabetes.
28 Movantik naloxegol Tuesday, September 16, 2014 To treat opioid-induced constipation in adults with chronic non-cancer pain.
27 Keytruda pembrolizumab Thursday, September 04, 2014 For treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.
26 Cerdelga eliglustat Tuesday, August 19, 2014 For the long-term treatment of adult patients with the Type 1 form of Gaucher disease
25 Plegridy peginterferon beta-1a Friday, August 15, 2014 For the treatment of patients with relapsing forms of multiple sclerosis
24 Belsomra suvorexant Wednesday, August 13, 2014 To treat difficulty in falling and staying asleep (insomnia)
23 Orbactiv oritavancin Wednesday, August 06, 2014 To treat adults with skin infections
22 Jardiance empagliflozin Friday, August 01, 2104 To improve gylcemic control in adults with type 2 diabetes
21 Striverdi Respimat olodaterol Thursday, July 31, 2014 To treat chronic obstructive pulmonary disease
20 Zydelig idelalisib Wednesday, July 23, 2014 To treat patients with trhee types of blood cancers
19 Kerydin tavaborole Monday, July 07, 2014 For the topical treatment of onychomycosis of the toenails
18 Beleodaq belinostat Thursday, July 03, 2014 To treat patients with peripheral T-cell lymphoma (PTCL)
17 Sivextro (tablet) tedizolid phosphate Friday, June 20, 2014 To treat adults with skin infections
16 Jublia efinaconazole Friday, June 06, 2014 Treat mild to moderate onychomycosis (fungal infection)
15 Dalvance dalbavancin Friday, May 23, 2014 To treat adults with skin infections
14 Entyvio vedolizumab Tuesday, May 20, 2014 To treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease
13 Zontivity vorapaxar Thursday, May 08, 2014 To reduce the risk of heart attacks and stroke in high-risk patients
12 Zykadia ceritinib Tuesday, April 29, 2014 To treat patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC)
11 Sylvant siltuximab Wednesday, April 23, 2014 To treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes)
10 Cyramza ramucirumab Monday, April 21, 2014 To treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma
9 Tanzeum albiglutide Tuesday, April 15, 2014 To improve glycemic control, along with diet and exercise, in adults with type 2 diabetes
8 Otezla apremilast Friday, March 21, 2014 To treat adults with active psoriatic arthritis (PsA)
7 Impavido miltefosine Wednesday, March 19, 2014 To treat a tropical disease called leishmaniasis
6 Neuraceq florbetaben F 18 injection Wednesday, March 19, 2014

For Positron EmissionTomography (PET) imaging of the brain

5 Myalept metreleptin for injection Monday, February 24, 2014 To treat the complications of leptin deficiency
4 Northera droxidopa Tuesday, February 18, 2014 To treat neurogenic orthostatic hypotension (NOH)
3 Vimizim elosulfase alfa Friday, February 14, 2014 Treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome)
2 Hetlioz tasimelteon Friday, January 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.
1 Farxiga dapaglifozin Wednesday, January 08, 2014 To improve glycemic control, along with diet and exercise, in adults with type 2 diabetes

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