Novel Drug Approvals for 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, CDER 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 have been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products approved by CDER in 2015. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2015 by the Center for Biologics Evaluation and Research.
- 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 Drug Trials Snapshot |
44. | Uptravi | selexipag | 12/21/2015 | To treat pulmonary arterial hypertension Drug Trials Snapshot |
43. | Bridion | sugammadex | 12/15/2015 |
To reverse effects of neuromuscular blocking drugs used during surgery |
42. | Alecensa | alectinib | 12/11/2015 | To treat ALK-positive lung cancer Drug Trials Snapshot |
41. | Kanuma | sebelipase alfa | 12/8/2015 | To treat patients with a rare disease known as lysosomal acid lipase (LAL) deficiency Drug Trials Snapshot |
40. | Empliciti | elotuzumab | 11/30/2015 |
To treat people with multiple myeloma who have received one to three prior medications |
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 Drug Trials Snapshot |
38. | Ninlaro | ixazomib | 11/20/2015 | To treat people with multiple myeloma who have received at least one prior therapy Drug Trials Snapshot |
37. | Darzalex | daratumumab | 11/16/2015 | To treat patients with multiple myeloma who have received at least three prior treatments. Drug Trials Snapshot |
36. | Tagrisso | osimertinib | 11/13/2015 | To treat certain patients with non-small cell lung cancer 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) 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 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. Drug Trials Snapshot |
32. | Strensiq | asfotase alfa | 10/23/2015 | To treat perinatal, infantile and juvenile-onset hypophosphatasia (HPP). 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). 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. 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. Drug Trials Snapshot |
28. | Aristada | aripiprazole lauroxil | 10/5/2015 | To treat adults with schizophrenia Drug Trials Snapshot |
27. | Tresiba | insulin degludec injection | 9/25/2015 | To improve blood sugar (glucose) control in adults with diabetes mellitus 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 Drug Trials Snapshot |
25. | Vraylar | cariprazine | 9/17/2015 | To treat schizophrenia and bipolar disorder in adults Drug Trials Snapshot for the treatment of bipolar disorder Drug Trials Snapshot for the treatment of schizophrenia |
24. | Xuriden | uridine triacetate | 9/4/2015 | To treat patients with hereditary orotic aciduria Drug Trials Snapshot |
23. | Varubi | rolapitant | 9/1/2015 | To prevent delayed phase chemotherapy-induced nausea and vomiting (emesis) Drug Trials Snapshot |
22. | Repatha | evolocumab | 8/27/2015 |
To treat certain patients with high cholesterol |
21. | Addyi | flibanserin | 8/18/2015 | To treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women Drug Trials Snapshot |
20. | Daklinza | daclatasvir | 7/24/2015 | To treat chronic hepatitis C virus (HCV) genotype 3 infections 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. Drug Trials Snapshot |
18. | Praluent | alirocumab | 7/24/2015 |
To treat certain patients with high cholesterol |
17. | Rexulti | brexpiprazole | 7/10/2015 | To treat schizophrenia and as an add on to an antidepressant to treat major depressive disorder 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 Drug Trials Snapshot |
15. | Orkambi | lumacaftor 200 mg/ivacaftor 125 mg | 7/2/2015 | To treat cystic fibrosis Drug Trials Snapshot |
14. | Kengreal |
cangrelor |
6/22/2015 | To prevent the formation of harmful blood clots in the coronary arteries for adult patients undergoing percutaneous coronary intervention Drug Trials Snapshot |
13. | Viberzi | eluxadoline | 5/27/2015 | To treat irritable bowel syndrome with diarrhea (IBS-D) in adult men and women. 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 Drug Trials Snapshot |
11. | Corlanor | ivabradine | 4/15/2015 | To reduce hospitalization from worsening heart failure. 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 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 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 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. Drug Trials Snaphot (cIAI) |
6. | Farydak | panobinostat | 2/23/2015 | To treat patients with multiple myeloma 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). Drug Trials Snapshot |
4. | Ibrance | palbociclib | 2/3/2015 | To treat advanced (metastatic) breast cancer Drug Trials Snapshot |
3. | Natpara | parathyroid horomone | 1/23/2015 | To control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism Drug Trials Snapshot |
2. | Cosentyx | secukinumab | 1/21/2015 | To treat adults with moderate-to-severe plaque psoriasis 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 Drug Trials Snapshot (atrial fibrillation) Drug Trials Snapshot (venous thromboembolism) |
*The listed “FDA-approved use” on this website is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, see the most recent FDA-approved Prescribing Information (click on the Drug Name).