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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
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| 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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2014 is positive for pharma R&D. Innovations are up. Great !!!