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27 Oct 2014

New molecule approved by USFDA tilldate in 2014

2014 New Molecule Approved tilldate
No. Drug Name Active Ingredient Date What It’s Used For
34 Esbriet pirfenidone 15-10-2014 For the treatment of idiopathic pulmonary fibrosis (IPF)
33 Ofev nintedanib 15-10-2014 For the treatment of idiopathic pulmonary fibrosis (IPF)
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
31 Akynzeo netupitant and palonosetron 10-10-2014 To treat nausea and vomiting in patients undergoing cancer chemotherapy
30 Harvoni ledipasvir/sofosbuvir 10-10-2014 To treat chronic hepatitis C virus (HCV) genotype 1 infection
29 Trulicity dulaglutide 18-09-2014 To treat adults with type 2 diabetes.
28 Movantik naloxegol 16-09-2014 To treat opioid-induced constipation in adults with chronic non-cancer pain.
27 Keytruda pembrolizumab 04-09-2014 For treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.
26 Cerdelga eliglustat 19-08-2014 For the long-term treatment of adult patients with the Type 1 form of Gaucher disease
25 Plegridy peginterferon beta-1a 15-08-2014 For the treatment of patients with relapsing forms of multiple sclerosis
24 Belsomra suvorexant 13-08-2014 To treat difficulty in falling and staying asleep (insomnia)
23 Orbactiv oritavancin 06-08-2014 To treat adults with skin infections
22 Jardiance empagliflozin 01-08-2104 To improve gylcemic control in adults with type 2 diabetes
21 Striverdi Respimat olodaterol 31-07-2014 To treat chronic obstructive pulmonary disease
20 Zydelig idelalisib 23-07-2014 To treat patients with trhee types of blood cancers
19 Kerydin tavaborole 07-07-2014 For the topical treatment of onychomycosis of the toenails
18 Beleodaq belinostat 03-07-2014 To treat patients with peripheral T-cell lymphoma (PTCL)
17 Sivextro (tablet) tedizolid phosphate 20-06-2014 To treat adults with skin infections
16 Jublia efinaconazole 06-06-2014 Treat mild to moderate onychomycosis (fungal infection)
15 Dalvance dalbavancin 23-05-2014 To treat adults with skin infections
14 Entyvio vedolizumab 20-05-2014 To treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease
13 Zontivity vorapaxar 08-05-2014 To reduce the risk of heart attacks and stroke in high-risk patients
12 Zykadia ceritinib 29-04-2014 To treat patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC)
11 Sylvant siltuximab 23-04-2014 To treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes)
10 Cyramza ramucirumab 21-04-2014 To treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma
9  Tanzeum albiglutide 15-04-2014 To improve glycemic control, along with diet and exercise, in adults with type 2 diabetes
8 Otezla apremilast 21-03-2014 To treat adults with active psoriatic arthritis (PsA)
7 Impavido miltefosine 19-03-2014 To treat a tropical disease called leishmaniasis
6 Neuraceq florbetaben F 18 injection 19-03-2014 For Positron EmissionTomography (PET) imaging of the brain
5 Myalept metreleptin for injection 24-02-2014 To treat the complications of leptin deficiency
4 Northera droxidopa 18-02-2014 To treat neurogenic orthostatic hypotension (NOH)
3 Vimizim elosulfase alfa 14-02-2014 Treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome)
2 Hetlioz tasimelteon 31-01-2014 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 08-01-2014 To improve glycemic control, along with diet and exercise, in adults with type 2 diabetes

Reference: USFDA official notification


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