New Drug Approvals in 2014
NEW MOLECULAR ENTITIY (NME) AND BIOLOGICAL DRUG (BLA) APPROVED in 2014 |
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Drug Name |
Active Ingredient |
Approval Date |
FDA-approved use |
|
| 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 |
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| 40. | Rapivab | peramivir | 12/19/2014 | To treat influenza infection in adults Press Release |
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| 39. | Zerbaxa | ceftolozane/tazobactam | 12/19/2014 | To treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) |
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| 38. | Viekira Pak | (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 |
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| 37. | Lynparza | olaparib | 12/19/2014 | To treat advanced ovarian cancer Press Release |
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| 36. | Xtoro | finafloxacin otic suspension | 12/17/2014 | To treat acute otitis externa, commonly known as swimmer’s ear Press Release |
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| 35. | Blincyto | blinatumomab | 12/3/2014 | To treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL) Press Release |
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| 34. | Esbriet | pirfenidone | 10/15/2014 | For the treatment of idiopathic pulmonary fibrosis (IPF) Press Release |
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| 33. | Ofev | nintedanib | 10/15/2014 | For the treatment of idiopathic pulmonary fibrosis (IPF) Press Release |
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| 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 |
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| 31. | Akynzeo | netupitant and palonosetron | 10/10/2014 | To treat nausea and vomiting in patients undergoing cancer chemotherapy Press Release |
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| 30. | Harvoni | ledipasvir/sofosbuvir | 10/10/2014 | To treat chronic hepatitis C virus (HCV) genotype 1 infection Press Release |
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| 29. | Trulicity | dulaglutide | 9/18/2014 | To treat adults with type 2 diabetes. Press Release |
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| 28. | Movantik | naloxegol | 9/16/2014 | To treat opioid-induced constipation in adults with chronic non-cancer pain. Press Release |
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| 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 |
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| 26. | Cerdelga | eliglustat | 8/19/2014 | For the long-term treatment of adult patients with the Type 1 form of Gaucher disease Press Release |
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| 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 |
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| 23. | Orbactiv | oritavancin | 8/6/2014 | To treat adults with skin infections Press Release |
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| 22. | Jardiance | empagliflozin | 8/1/2104 | To improve gylcemic control in adults with type 2 diabetes Press Release |
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| 21. | Strivrdi Respimat |
olodaterol | 7/31/2014 | To treat chronic obstructive pulmonary disease Press Release |
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| 20. |
Zydelig | idelalisib | 7/23/2014 | To treat patients with trhee types of blood cancers Press Release |
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| 19. | Kerydin |
tavaborole | 7/7/2014 | For the topical treatment of onychomycosis of the toenails (No Press Release) |
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| 18. | Beleodaq | belinostat | 7/3/2014 | To treat patients with peripheral T-cell lymphoma (PTCL) Press Release |
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| 17. | Sivextro (tablet) Sivextro (injection) |
tedizolid phosphate | 6/20/2014 | To treat adults with skin infections Press Release |
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| 16. | Jublia |
efinaconazole | 6/6/2014 | Treat mild to moderate onychomycosis (fungal infection) No Press Release |
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| 15. | Dalvance |
dalbavancin | 5/23/2014 | To treat adults with skin infections Press Release |
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| 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 |
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| 13. | Zontivity |
vorapaxar | 5/8/2014 | To reduce the risk of heart attacks and stroke in high-risk patients Press Release |
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| 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 |
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| 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 |
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| 10. | Cyramza |
ramucirumab | 4/21/2014 | To treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma Press Release |
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| 9. | Tanzeum |
albiglutide | 4/15/2014 | To improve glycemic control, along with diet and exercise, in adults with type 2 diabetes Press Release |
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| 8. | Otezla |
apremilast | 3/21/2014 | To treat adults with active psoriatic arthritis (PsA) Press Release |
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| 7. | Impavido |
miltefosine | 3/19/2014 | To treat a tropical disease called leishmaniasis Press Release |
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| 6. | Neuraceq |
florbetaben F 18 injection | 3/19/2014 | For Positron EmissionTomography (PET) imaging of the brain |
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| 5. | Myalept |
metreleptin for injection | 2/24/2014 | To treat the complications of leptin deficiency Press Release |
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| 4. | Northera |
droxidopa | 2/18/2014 | To treat neurogenic orthostatic hypotension (NOH) Press Release |
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| 3 | Vimizim | elosulfase alfa | 2/14/2014 | Treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome) |
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| 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. |
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| 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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Source: Food and Drug Administration. Press Releases link to FDA web site.