Savaysa® (edoxaban) is indicated to reduce the risk of stroke and other conditions caused by blood clots (thromboembolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
Read more


Cosentyx® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
Read more


Natpara® (parathyroid hormone) is indicated for hypoparathyroidism in combination with calcium and vitamin D.
Read more


Ibrance®(palbociclib) is indicated for postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.
Read more


Lenvima (lenvatinib mesylate) is indicated for patients with differentiated thyroid cancer (DTC) that has progressed despite radioactive iodine therapy (radioactive iodine refractory disease).
Read more


Farydak® (panobinostat lactate) is given in combination with bortezomib (BTZ) and dexamethasone (Dex) for the treatment of multiple myeloma.
Read more


Ayvcaz (ceftazidime-avibactam) is for the treatment of Complicated Urinary Tract Infections (cUTI) including Pyelonephritis and Complicated Intra-abdominal Infections (cIAI).
Read more


Cresemba® (isavuconazonium sulfate) is a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections.
Read more


Unituxin (dinutuximab) is an antibody that is part of first-line therapy for pediatric patients with high-risk neuroblastoma, the most common cancer in infancy.
Read more


Cholbam® (cholic acid) is indicated for the treatment of pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects and for patients with peroxisomal disorders (including Zellweger spectrum disorders).
Read more


Corlanor® (ivabradine) is indicated in patients who have chronic left ventricular heart failure.
Read more


kybella (deoxycholic acid) is indicated in adults for improvement in the appearance of moderate to severe convexity (fullness) associated with fat below the chin.
Read more


Viberzi (eluxadoline) is indicated for adults who have irritable bowel syndrome with diarrhea (IBS-D).
Read more


Kengreal (cangrelor) is indicated for reducing the risk of heart attack and other thrombotic (clotting) events during medical procedures in patients who have not been treated with a P2Y12 inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor (GPI).
Read more


Orkambi (lumacaftor/ivacaftor) is indicated for patients with cystic fibrosis age 12 and older who have two copies of the F508del mutation.
Read more


Entresto (sacubitril/valsartan) is a cardiostimulant for the treatment of NYHA class II-IV heart failure with reduced ejection fraction.
Read more


REXULTI® (brexpiprazole) is indicated for adjunctive treatment of major depressive disorder and schizophrenia.
Read more


Praluent® (alirocumab) is a fully-human monoclonal antibody (mAb) indicated for the treatment of hypercholesterolemia.
Read more


Odomzo (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy or those who are not candidates for surgery or radiation therapy.
Read more


Daklinza® (daclatasvir) is indicated in combination with sofosbuvir for the treatment of Hepatitis C virus (HCV) infection.
Read more


Addyi (flibanserin) is indicated for the treatment of generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
Read more


Repatha (evolocumab) is indicated for treatment of hypercholesterolemia in patients with elevated levels of LDL due to inherited conditions and those with history of heart attack, stroke and other cardiovascular problems.
Read more


Varubi (rolapitant) is indicated for the treatment of chemotherapy-induced nausea and vomiting.
Read more


Xuriden(uridine triacetate) is for patients with hereditary orotic aciduria.
Read more


Vraylar(cariprazine) is for the treatment of acute manic or mixed episodes associated with bipolar 1 disorder and schizophrenia.
Read more


Lonsurf(trifluridine and tipiracil) for patients with metastatic colorectal cancer who are no longer responding to other therapies.
Read more


Tresiba®(insulin degludec injection) is indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus.
Read more


AristadaTM(aripiprazole lauroxil) is for the treatment of adults with schizophrenia.
Read more


Praxbind®(idarucizumab) is indicated in patients treated with Pradaxa® when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding.
Read more


VeltassaTM(patiromer) is for the treatment hyperkalemia.
Read more


YondelisTM(trabectedin) is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.
Read more


StrensiqTM(asfotase alfa) is the first approved treatment for perinatal, infantile and juvenile-onset hypophosphatasia (HPP).
Read more


Nucala®(mepolizumab) is the first anti-IL5 treatment for adults and adolescents with severe asthma with an eosinophilic phenotype.
Read more


Genvoya®(Elvitegravir;Cobicistat;
Emtricitabine;Tenofovir Alafenamide) the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.
Read more


Cotellic®(Cobimetinib) is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with ZELBORAF (vemurafenib).
Read more


Tagrisso®(osimertinib) is the only approved medicine indicated for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer.
Read more


DarzalexTM(daratumumab) is for the treatment of patients with multiple myeloma who have received at least three prior treatments.
Read more


Ninlaro®(ixazomib) works in combination with Revlimid (lenalidomide) and dexamethasone to treat people with multiple myeloma who have received at least one prior therapy.
Read more


PortrazzaTM(necitumumab) is used in combination with gemcitabine and cisplatin, as the first biologic for the first-line treatment of people with metastatic squamous non-small cell lung cancer (NSCLC). Portrazza is not indicated for treatment of nonsquamous NSCLC.
Read more


EmplicitiTM(elotuzumab) is used in combination with Revlimid (lenalidomide) and dexamethasone (Decadron) to treat people with multiple myeloma who have received one to three prior medications.
Read more


KanumaTM(sebelipase alfa) is for the treatment of patients with Lysosomal Acid Lipase Deficiency (LAL-D).
Read more


Alecensa®(alectinib) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or could not tolerate treatment with Pfizer Inc.’s Xalkori (crizotinib).
Read more


Bridion®(sugammadex) is used to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.
Read more


Uptravi®(selexipag) to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation.
Read more


Zurampic®(lesinurad) is for the treatment of high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI)
Read more


By FDA standards a drug is considered novel if it contains no active moiety previously approved by the FDA. An active moiety is the part of the drug that is responsible for the drug’s physiologic or pharmacologic action. In other words, it’s the business part of the drug that ultimately elicits the effects (both good and bad) that are seen when the drug is administered to patients. It should be noted that a drug can still be considered novel if it has the same mechanism of action of other previously approved drugs. In the case of a novel drug, the effect seen in the body (ie, what enzyme is being inhibited leading to a physiologic response) doesn’t have to be new, but the specific part of the drug molecule that facilitates that response does. If a novel drug uses a new or unique mechanism of action, it is considered “first in class”.

 Statistics By Approval Designation

As of 12/22/15 and out of 45 approved novel new drugs. Drugs can be counted across multiple categories.

Like this page? Share it!

16
First-in-Class
24
Priority Review
10
Breakthrough Therapy
14
Fast-Track
6
Accelerated Approval
21
Orphan Status

Designations By Drug Name

First-In-Class

  1. Cosentyx

  2. Ibrance

  3. Unituxin

  4. Cholbam

  5. Corlanor

  6. Entresto

  7. Pralulent

  8. Addyi

  9. Xuriden

  10. Praxbind

  11. Strensiq

  12. Nucala

  13. Darsalex

  14. Ninlaro

  15. Empliciti

  16. Kanuma

  17. Bridion

Priority Review

  1. Ibrance

  2. Lenvima

  3. Farydak

  4. Avycaz

  5. Cresemba

  6. Unituxin

  7. Cholbam

  8. Corlanor

  9. Viberzi

  10. Orkambi

  11. Entresto

  12. Daklinza

  13. Xuriden

  14. Praxbind

  15. Yondelis

  16. Strensiq

  17. Cotellic

  18. Tagrisso

  19. Darzalex

  20. Ninlaro

  21. Empliciti

  22. Kanuma

  23. Alcensa

  24. Bridion

Breakthrough Therapy

  1. Ibrance

  2. Orkambi

  3. Repatha

  4. Xuriden

  5. Praxbind

  6. Strensiq

  7. Tagrisso

  8. Empliciti

  9. Kanuma

  10. Alecensa

Fast-Track

  1. Avycaz

  2. Corlanor

  3. Viberzi

  4. Orkambi

  5. Entresto

  6. Daklinza

  7. Lonsurf

  8. Strensiq

  9. Genvoya

  10. Cotellic

  11. Tagrisso

  12. Darzalex

  13. Portrazza

  14. Kanuma

Accelerated Approval

  1. Ibrance

  2. Farydak

  3. Praxbind

  4. Tagrisso

  5. Darzalex

  6. Alecensa

Orphan Status

  1. Natpara

  2. Lenvima

  3. Farydak

  4. Cresemba

  5. Unituxin

  6. Cholbam

  7. Orkambi

  8. Repatha

  9. Xuriden

  10. Praxbind

  11. Yondelis

  12. Strensiq

  13. Cotellic

  14. Tagrisso

  15. Darzalex

  16. Ninlaro

  17. Portrazza

  18. Empliciti

  19. Kanuma

  20. Alecensa

  21. Uptravi

Like this page? Share it!

 Statistics By Drug Category

As of 12/22/15 and out of 45 approved novel new drugs. Drugs can be counted across multiple categories.

Drugs by Category Name

Oncology

  1. Ibrance

  2. Lenvima

  3. Farydak

  4. Unituxin

  5. Odomzo

  6. Varubi

  7. Lonsurf

  8. Yondelis

  9. Cotellic

  10. Tagrisso

  11. Darzalex

  12. Ninlaro

  13. Portrazza

  14. Empliciti

  15. Alecensa

Cardiology

  1. Savaysa

  2. Corlanor

  3. Kengreal

  4. Entresto

  5. Praluent

  6. Repatha

  7. Uptravi

Infectious Disease

  1. Avycaz

  2. Cresemba

  3. Daklinza

  4. Genvoya

Dermatology

  1. Cosentyx

  2. Kybella

  3. Odomzo

  4. Cotellic

Women's Health

  1. Ibrance

  2. Addyi

Gastroenterology

  1. Avycaz

  2. Cholbam

  3. Viberzi

  4. Varubi

Endocrinology

  1. Natpara

  2. Addyi

  3. Tresiba

Pediatrics

  1. Ibrance

  2. Unituxin

  3. Cholbam

  4. Orkambi

  5. Xuriden

  6. Strensiq

  7. Kanuma

Respiratory

  1. Orkambi

  2. Nucala

  3. Portrazza

Mental Health

  1. Rexulti

  2. Vraylar

  3. Aristada

Metabolic

  1. Xuriden

  2. Kanuma

Hematology

  1. Natpara

  2. Farydak

  3. Praxbind

  4. Veltassa

Orthopedic

  1. Strensiq

Genetic

  1. Strensiq

  2. Kanuma

Nephrology

  1. Zurampic

15
Oncology
7
Cardiology
4
Infectious Disease
4
Dermatology
2
Women's Health
4
Gastroenterology
2
Endocrinology
6
Pediatrics
3
Respiratory
3
Mental Health
4
Hematology
2
Metabolic
1
Orthopedic
1
Nephrology
2
Genetic