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Drug Trials Snapshots

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WHAT IS THE PURPOSE OF DRUG TRIALS SNAPSHOTS?

Drug Trials Snapshots provide consumers with information about who participated in clinical trials that supported the FDA approval of new drugs. The information provided in these Snapshots also highlights whether there were any differences in the benefits and side effects among sex, race and age groups. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent.

HOW TO USE SNAPSHOTS:

Each Snapshot contains information about the drug in a question and answer format. At the end of each section of the Snapshot, there is a shaded bar with the words “MORE INFO”. Click the “MORE INFO” bar for more technical and detailed content. At the bottom of each Snapshot, there is a link to the drug’s Package Insert as well as the medical review.

LIMITATIONS OF SNAPSHOTS:

The Snapshot is intended as one tool for consumers to use when discussing a drug’s risks and benefits with their physician. Do not rely on Snapshots alone to make decisions regarding medical care. Do not use Snapshots to substitute for advice from your health care professional.  Conclusions regarding how effective and safe a drug is among different sex, race, and age groups cannot always be made, often because the numbers of patients in some groups are too limited to allow for meaningful comparisons to other groups and to the overall results.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

Drug Active Ingredient Date of FDA Approval What is it Approved For Package Insert
ADDYI flibanserin August 18, 2015 Treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women Addyi
ALECENSA alectinib December 11, 2015 For the treatment of metastatic non-small cell lung cancer Alecensa
ANTHIM obiltoxaximab March 18, 2016 For the treatment of inhalational anthrax ANTHIM
ARISTADA aripiprazole laurixil October 5, 2015 Treatment of schizophrenia Aristada
AVYCAZ ceftazidime-avibactam February 25, 2015 Treatment of complicated intra-abdominal infection (abbreviated as cIAI)  Avycaz
AVYCAZ ceftazidime-avibactam February 25, 2015 Treatment of complicated urinary tract infection (abbreviated as cUTI) Avycaz
AXUMIN fluciclovine F 18 May 27, 2016 Detection of prostate cancer recurrence Axumin
BRIDION  sugammadex  December 15, 2015   For the reversal of the effects of certain neuromuscular blocking agents  Bridion 
BRIVIACT  brivaracetam  February 18, 2016   Treatment of partial-onset seizures  Briviact 
CHOLBAM  cholic acid March 17, 2015 For treatment of bile acid synthesis disorders due to single enzyme defects  Cholbam 
CHOLBAM  cholic acid March 17, 2015 For treatment of peroxisomal disorders, including Zellweger spectrum disorders  Cholbam
CINQUAIR  reslizumab March 23, 2016 For the treatment of a specific type of severe asthma (called eosinophilic phenotype asthma) Cinquair
CORLANOR  ivabradine April 15, 2015 To reduce hospitalization from worsening heart failure. Corlanor
COSENTYX secukinumab January 21, 2015 Treatment of moderate to severe plaque psoriasis in adults who do not respond well to medication applied directly to the skin Cosentyx
COTELLIC (cobimetinib) November 10, 2015 Part of combination treatment melanoma Cotellic
CRESEMBA isavuconazonium sulfate March 6, 2015 Treatment of invasive aspergillosis Cresemba
CRESEMBA isavuconazonium sulfate March 6, 2015 Treatment of invasive mucormycosis Cresemba
DAKLINZA daclatasvir July 24, 2015 Treatment of chronic Hepatitis C genotype 3 infection Daklinza
DALVANCE dalbavancin hydrochloride May 23, 2014 Treatment of serious bacterial skin infections Dalvance
DARZALEX daratumumab November 16, 2015 Treatment of multiple myeloma Darzalex
DEFITELIO defibrotide sodium March 30, 2016 Treatment of hepatic veno-occlusive disease (VOD) Defitelio
EMPLICITI elotuzumab November 30, 2015 Treatment of multiple myeloma Empliciti
ENTRESTO secubitril/valsartan July 7, 2015 Treatment of heart failure Entresto 
ENTYVIO vedolizumab May 20, 2014 Treatment of Crohn’s Disease Entyvio
ENTYVIO vedolizumab May 20, 2014 Treatment of Ulcerative Colitis Entyvio
EPCLUSA sofosbuvir and velpatasvir June 28, 2016 Treatment of chronic Hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection. Epclusa
FARYDAK panobinostat February 23, 2015 Treatment of multiple myeloma Farydak
GENVOYA elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide November 5, 2015 Complete regimen for the treatment of HIV-1 in adults and children 12 years of age and older. Genvoya
IBRANCE palbociclib February 3, 2015 Treatment of a specific form of advanced breast cancer called ER-positive, HER2-negative (ER+/HER-) breast cancer in women who have gone through menopause (post-menopausal) Ibrance
JUBLIA efinaconazole June 6, 2014 Treatment of fungal infection of the toenails due to two common forms of fungi Jublia
KANUMA sebelipase alfa December 8, 2015 Treatment of Lysosomal Acid Lipase (LAL) deficiency Kanuma
KENGREAL cangrelor June 22, 2015 For prevention of coronary artery blood clot formation in patients undergoing PCI Kengreal
KYBELLA deoxycholic acid April 29, 2015 Treatment for double chin Kybella
LENVIMA lenvatinib February 13, 2015 Treatment of progressive, differentiated thyroid cancer (DTC) that can no longer be treated with radioactive iodine  Lenvima
LONSURF trifluridine and tipiracil September 22, 2015 Treatment of advanced colorectal cancer Lonsurf
NATPARA parathyroid hormone January 25, 2015 For control of hypocalcemia along with calcium and vitamin D in adults with hypoparathyroidism Natpara
NETSPOT kit for the preparation of gallium Ga 68 dotatate injection June 1, 2016 For detection of a specific type of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs) Netspot
NINLARO ixazomib  November 20, 2015  Treatment of multiple myeloma  Ninlaro 
NUCALA mepolizumab November 4, 2015 For the treatment of a specific type of severe asthma (called eosinophilic phenotype asthma) Nucala
NUPLAZID pimavanserin April 29, 2016 Treatment of hallucinations and delusions in patients with Parkinson’s disease Nuplazid
OCALIVA obeticholic acid May 27, 2016 Treatment of primary biliary cholangitis in adults Ocaliva
ODOMZO  sonidegib July 24, 2015 Treatment of locally advanced basal cell carcinoma  Odomzo
ORKAMBI lumacaftor/ivacaftor July 2, 2015 Treatment of cystic fibrosis Orkambi
PORTRAZZA necitumumab November 24, 2015 For the treatment of metastatic squamous non-small cell lung cancer Portrazza
PRALUENT  alirocumab July 24, 2015 Treatment of certain patients with high cholesterol  Praluent 
PRAXBIND idarucizumab October 16, 2015 Reversal of the anticoagulant effects of Pradaxa during emergency situations or when there is a need to reverse its blood-thinning effects. Praxbind
REPATHA evolocumab August 27, 2015 Treatment of certain patients with high cholesterol Repatha
REXULTI brexpiprazole July 10, 2015 Treatment of major depressive disorder Rexulti 
REXULTI brexpiprazole July 10, 2015 Treatment of schizophrenia Rexulti
RYZODEG insulin degludec and insulin aspart injection September 26, 2015 Improves blood sugar control in adults with diabetes mellitus (DM) Ryzodeg
SAVAYSA edoxaban January 8, 2015  Prevention of stroke in patients with atrial fibrillation Savaysa  
SAVAYSA edoxaban January 8, 2015 Reduction of risk of venous thromboembolism (VTE) in patients with previous VTE Savaysa
SIVEXTRO tedizolid June 20, 2014 Treatment of serious bacterial skin infections known as acute bacterial skin and skin structure infections Sivextro
STIOLTO RESPIMAT tiotropium bromide and olodaterol May 21, 2015 Long-term treatment of COPD Stiolto Respimat
STRENSIQ asfotase alfa  October 23, 2015  Treatment of perinatal, infantile and juvenile-onset hypophosphatasia (HPP)  Strensiq 
TAGRISSO osimertinib  December 3, 2015 Treatment of patients with advanced non-small cell lung cancer (NSCLC)   Tagrisso 
TALTZ ixekizumab March 22, 2016 Treatment of moderate to severe plaque psoriasis in adults Taltz
TECENTRIQ atezolizumab May 18, 2016 Treatment of a type of bladder cancer called urothelial carcinoma Tecentriq
TRESIBA insulin degludec injection  September 26, 2015  To improve glucose control in adults with diabetes mellitus  Tresiba 
UNITUXIN  dinutuximab March 10, 2015 Treatment of children with high-risk neuroblastoma Unituxin
UPTRAVI selexipag December 21, 2015 For the treatment of adults with pulmonary artery hypertension Uptravi
VARUBI rolapitant September 1, 2015 To prevent delayed phase chemotherapy-induced nausea and vomiting Varubi
VELTASSA patiromer October 21, 2015 Treatment of hyperkalemia Veltassa
VENCLEXTA venetoclax April 11, 2016 Treatment of chronic lymphocytic leukemia (CLL) Venclexta
VIBERZI eluxadoline May 27, 2015 Treatment of irritable bowel syndrome with diarrhea Viberzi
VISTOGARD uridine triacetate December 11, 2015 For the  emergency treatment of an overdose with fluorouracil or capecitabine Vistogard
VRAYLAR cariprazine September 17, 2015 Treatment of bipolar disorder Vraylar
VRAYLAR cariprazine September 17, 2015 Treatment of schizophrenia Vraylar
XURIDEN uridine triacetate September 4, 2015 Treatment of patients with hereditary orotic aciduria Xuriden
YONDELIS  trabectedin  October 23, 2015  Treatment of certain types of advances tissue sarcoma   Yondelis 
ZEPATIER elbasvir and grazoprevir January 28, 2016 Treatment of chronic Hepatis C genotypes 1 or 4 infection Zepatier
ZINBRYTA daclizumab May 27, 2016 Treatment of relapsing forms of multiple sclerosis (MS) Zinbryta
ZONTIVITY vorapaxar May 8, 2014 Reduction of heart attacks and stroke in high-risk patients Zontivity
ZURAMPIC lesinurad December 22, 2015 For lowering uric acid levels in the blood of adult patients with gout Zurampic 

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Page Last Updated: 08/18/2016
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