Drugs

Novel Drug Approvals for 2015

Novel Drugs 2015

2015 Novel Drugs Summary (PDF - 16MB)
Text Version
Updated as of 2/5/16, corrects images on page 11

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
45. Zurampic lesinurad 12/22/2015 To treat high blood uric acid levels associated with gout
Press Release
Drug Trials Snapshot
44. Uptravi selexipag 12/22/2015 To treat pulmonary arterial hypertension
Press Release
Drug Trials Snapshot
43. Bridion sugammadex 12/15/2015

To reverse effects of neuromuscular blocking drugs used during surgery
Press Release
Drug Trials Snapshot

42. Alecensa alectinib 12/11/2015 To treat ALK-positive lung cancer
Press Release
Drug Trials Snapshot
41. Kanuma sebelipase alfa 12/8/2015 To treat patients with a rare disease known as lysosomal acid lipase (LAL) deficiency
Press Release
Drug Trials Snapshot
40. Empliciti elotuzumab 11/30/2015

To treat people with multiple myeloma who have received one to three prior medications
Press Release
Drug Trials Snapshot

39. Portrazza necitumumab 11/24/2015 To treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer
Press Release
Drug Trials Snapshot
38. Ninlaro ixazomib 11/20/2015 To treat people with multiple myeloma who have received at least one prior therapy
Press Release
Drug Trials Snapshot
37. Darzalex daratumumab 11/16/2015 To treat patients with multiple myeloma who have received at least three prior treatments.
Press Release
Drug Trials Snapshot
36. Tagrisso osimertinib 11/13/2015 To treat certain patients with non-small cell lung cancer
Press Release
Drug Trials Snapshot
35. Cotellic cobimetinib 11/10/2015 To be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation)
Press Release
Drug Trials Snapshot
34. Genvoya a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide 11/5/2015 For use as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older
Press Release
Drug Trials Snapshot
33. Nucala mepolizumab 11/4/2015 For use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older.
Press Release
32. Strensiq asfotase alfa 10/23/2015 To treat perinatal, infantile and juvenile-onset hypophosphatasia (HPP).
Press Release
Drug Trials Snapshot
31. Yondelis trabectedin 10/23/2015 To treat specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic).
Press Release
Drug Trials Snapshot
30. Veltassa patiromer for oral suspension 10/21/2015 To treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high.
Press Release
Drug Trials Snapshot
29. Praxbind idarucizumab 10/16/2015 For use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.
Press Release
Drug Trials Snapshot
28. Aristada aripiprazole lauroxil 10/6/2015 To treat adults with schizophrenia
Press Release
Drug Trials Snapshot
27. Tresiba insulin degludec injection 9/25/2015 To improve blood sugar (glucose) control in adults with diabetes mellitus
Press Release
Drug Trials Snapshot
26. Lonsurf trifluridine and tipiracil 9/22/2015 To treat patients with an advanced form of colorectal cancer who are no longer responding to other therapies
Press Release
Drug Trials Snapshot
25. Vraylar cariprazine 9/17/2015 To treat schizophrenia and bipolar disorder in adults
Press Release
Drug Trials Snapshot
24. Xuriden uridine triacetate 9/4/2015 To treat patients with hereditary orotic aciduria
Press Release
Drug Trials Snapshot
23. Varubi rolapitant 9/2/2015 To prevent delayed phase chemotherapy-induced nausea and vomiting (emesis)
Press Release
Drug Trials Snapshot
22. Repatha evolocumab 8/27/2015

To treat certain patients with high cholesterol
Press Release
Drug Trials Snapshot

21. Addyi flibanserin 8/18/2015 To treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women
Press Release
Drug Trials Snapshot
20. Daklinza daclatasvir 7/24/2015 To treat chronic hepatitis C virus (HCV) genotype 3 infections
Press Release
Drug Trials Snapshot
19. Odomzo sonidegib 7/24/2015 To treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.
Press Release
Drug Trials Snapshot
18. Praluent alirocumab 7/24/2015

To treat certain patients with high cholesterol
Press Release
Drug Trials Snapshot

17. Rexulti brexpiprazole 7/10/2015 To treat schizophrenia and as an add on to an antidepressant to treat major depressive disorder
Press Release 
Drug Trials Snapshot (treatment of major depressive disorder)
Drug Trials Snapshot (treatment of schizophrenia)
16. Entresto sacubitril/valsartan 7/7/2015 To treat heart failure
Press Release
Drug Trials Snapshot
15. Orkambi lumacaftor 200 mg/ivacaftor 125 mg 7/2/2015 To treat cystic fibrosis
Press Release
Drug Trials Snapshot
14. Kengreal

canegrelor

6/22/2015 To prevent the formation of harmful blood clots in the coronary arteries for adult patients undergoing percutaneous coronary intervention
Press Release
Drug Trials Snapshot
13. Viberzi eluxadoline 5/27/2015 To treat irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.
Press Release
Drug Trials Snapshot
12. Kybella deoxycholic acid 4/29/2015 To treat adults with moderate-to-severe fat below the chin, known as submental fat
Press Release
Drug Trials Snapshot
11. Corlanor ivabradine 4/15/2015 To reduce hospitalization from worsening heart failure.
Press Release
Drug Trials Snapshot
10. Cholbam cholic acid 3/17/2015 To treat pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders
Press Release
Drug Trials Snapshot (bile acid synthesis disorders)
Drug Trials Snapshot (peroxisomal disorders)
9. Unituxin dinutuximab 3/10/2015 To treat pediatric patients with high-risk neuroblastoma
Press Release
Drug Trials Snapshot
8. Cresemba
capsule
injection
isavuconazonium sulfate
 
3/6/2015 To treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections
Press Release
Drug Trials Snapshot (aspergillosis)
Drug Trials Snapshot (mucormycosis) 
7. Avycaz ceftazidime-avibactam 2/25/2015 To treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.
Press Release
Drug Trials Snaphot (cIAI) 
Drug Trials Snapshot (cUTI) 
6. Farydak panobinostat 2/23/2015 To treat patients with multiple myeloma
Press Release
Drug Trials Snapshot
5. Lenvima lenvatinib 2/13/2015 To treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).
Press Release
Drug Trials Snapshot
4. Ibrance palbociclib 2/3/2015 To treat advanced (metastatic) breast cancer
Press Release
Drug Trials Snapshot
3. Natpara parathyroid horomone 1/23/2015 To control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism
Press Release
Drug Trials Snapshot
2. Cosentyx secukinumab 1/21/2015 To treat adults with moderate-to-severe plaque psoriasis
Press Release
Drug Trials Snapshot
1. Savaysa edoxaban  1/8/2015 To reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem
Press Release
Drug Trials Snapshot (atrial fibrillation) 
Drug Trials Snapshot (venous thromboembolism)

* This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug’s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA).  For instance, new information may become available which could lead to a reconsideration of the original designation or status.  If changes must be made to a drug’s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.

Page Last Updated: 11/04/2016
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