New Drugs 2014-2018

NEW DRUGS 2018 01 TO 59
APPROVED BY
US FDA
NEW DRUGS
2018 US FDA [01 TO 59]
59 Ultomiris 12/21/2018 To treat paroxysmal nocturnal

ravulizumab hemoglobinuria (PNH)
58. Elzonris tagraxofusp-erzs 12/21/2018 To treat blastic plasmacytoid

dendritic cell neoplasm (BPDCN)
57. Asparlas calaspargase 12/20/2018 To treat acute lymphoblastic

pegol-mknl leukemia (ALL) in pediatric and
young adult patients age 1
month to 21 years
56. Motegrity prucalopride 12/14/2018 To treat chronic idiopathic

constipation
55. Xospata gilteritinib 11/28/2018 To treat patients who have

relapsed or refractory acute
myeloid leukemia (AML)
54. Firdapse amifampridine 11/28/2018 To treat Lambert-Eaton

myasthenic syndrome (LEMS) in
adults
53. Vitrakvi larotrectinib 11/26/2018 To treat patients whose cancers
have a specific genetic feature
(biomarker)
52. Daurismo glasdegib 11/21/2018 To treat newly-diagnosed acute

myeloid leukemia (AML) in adult
patients
51. Gamifant emapalumab- 11/20/2018 To treat primary hemophagocytic

lzsg lymphohistiocytosis (HLH)
50. Aemcolo rifamycin 11/16/2018 To treat travelers’ diarrhea
49. Yupelri revefenacin 11/8/2018 To treat patients with chronic

obstructive pulmonary disease
(COPD)
48. Lorbrena lorlatinib 11/2/2018 To treat patients with anaplastic

lymphoma kinase (ALK)-positive
metastatic non-small cell lung
cancer
47. Xofluza baloxavir 10/24/2018 For the treatment of acute
marboxil uncomplicated influenza in
patients who have been
symptomatic for no more than 48
hours.
For the treatment of locally

46. Talzenna talazoparib 10/16/2018 advanced or metastatic breast
cancer patients with a germline
BRCA mutation.
45. Tegsedi inotersen 10/5/2018 To treat polyneuropathy of

hereditary transthyretin-
mediated amyloidosis in adults
44. Revcovi elapegademase- 10/5/2018 To treat Adenosine Deaminase-

lvlr Severe Combined
Immunodeficiency (ADA-SCID)
43. Nuzyra omadacycline 10/3/2018 To treat community-acquired

bacterial pneumonia and acute
bacterial skin and skin structure
infections
42. Seysara sarecycline 10/1/2018 To treat inflammatory lesions of

non-nodular moderate to severe
acne vulgaris in patients 9 years
of age and older
41. Libtayo cemiplimab-rwlc 9/28/2018 To treat cutaneous squamous

cell carcinoma (CSCC)
40. Vizimpro dacomitinib 9/27/2018 To treat metastatic non-small-

cell lung cancer
39. Emgality galcanezumab- 9/27/2018 For the preventive treatment of

gnlm migraine in adults
38 Copiktra duvelisib 9/24/2018 To treat relapsed or refractory

chronic lymphocytic leukemia,
small lymphocytic lymphoma
and follicular lymphoma
37. Ajovy fremanezumab- 9/14/2018 For the preventive treatment of

vfrm migraine in adults
36. Lumoxiti moxetumomab 9/13/2018 To treat hairy cell leukemia

pasudotox-tdfk
35. Pifeltro doravirine 8/30/2018 To treat HIV-1 infection in adult

patients
34. Xerava eravacycline 8/27/2018 To treat complicated intra-

abdominal infections in patients
18 years of age and older
33. Takhzyro lanadelumab 8/23/2018 To treat types I and II hereditary

angioedema
32. Oxervate cenegermin-bkbj 8/22/2018 To treat neurotrophic keratitis
31. Diacomit stiripentol 8/20/2018 To treat seizures associated with

Dravet syndrome in patients 2
years of age and older taking
clobazam
30. Galafold migalastat 8/10/2018 To treat treat adults with Fabry

disease.
29. Annovera segesterone 8/10/2018 New vaginal ring used to prevent

acetate and pregnancy for an entire year
ethinyl estradiol
vaginal system
28. Onpattro patisiran 8/10/2018 To treat the polyneuropathy of

hereditary transthyretin-
mediated amyloidosis in adult
patients
27. Poteligeo mogamulizumab- 8/8/2018 To treat two rare types of non-
kpkc Hodgkin lymphoma
26. Mulpleta lusutrombopag 7/31/2018 To treat thrombocytopenia in

adult patients with chronic liver
disease who are scheduled to
undergo a procedure
25. Omegaven fish oil 7/27/2018 As a source of calories and fatty

triglycerides acids in pediatric patients with
parenteral nutrition-associated
cholestasis
24. Orilissa elagolix sodium 7/23/2018 For the management of

moderate to severe pain
associated with endometriosis
23. Krintafel tafenoquine 7/20/2018 For the radical cure (prevention

of relapse) of Plasmodium vivax
malaria
22. Tibsovo ivosidenib 7/20/2018 To treat patients with relapsed or

refractory acute myeloid
leukemia
21. TPOXX tecovirimat 7/13/2018 To treat smallpox
20. Braftovi encorafenib 6/27/2018 To treat unresectable or

metastatic melanoma
19. Mektovi binimetinib 6/27/2018 To treat unresectable or

metastatic melanoma
18. Zemdri plazomicin 6/25/2018 To treat adults with complicated

urinary tract infections
17. Epidiolex cannabidiol 6/25/2018 To treat rare, severe forms of

epilepsy
16. Moxidectin moxidectin 6/13/2018 To treat onchocerciasis due to
Onchocerca volvulus in patients
aged 12 years and older
15. Olumiant baricitinib 5/31/2018 To treat moderately to severely

active rheumatoid arthritis
14. Palynziq pegvaliase-pqpz 5/24/2018 To treat adults with a rare and

serious genetic disease known
as phenylketonuria (PKU)
13. Doptelet avatrombopag 5/21/2018 To treat low blood platelet count

(thrombocytopenia) in adults
with chronic liver disease who
are scheduled to undergo a
medical or dental procedure
12. Lokelma sodium 5/18/2018 To treat hyperkalemia

zirconium
cyclosilicate
11. Aimovig erenumab-aooe 5/17/2018 For the preventive treatment for

migraine
10. Lucemyra lofexidine 5/16/2018 For the non-opioid treatment for

hydrochloride management of opioid
withdrawal symptoms in adults
9. Akynzeo fosnetupitant and 4/19/2018 To prevent acute and delayed

palonosetron nausea and vomiting associated
with initial and repeat courses of
highly emetogenic cancer
chemotherapy
8. Crysvita burosumab-twza 4/17/2018 To treat adults and children ages

1 year and older with x-linked
hypophosphatemia (XLH), a
rare, inherited form of rickets
7. Tavalisse fostamatinib 4/17/2018 To treat thrombocytopenia in

adult patients with persistent or
chronic immune
thrombocytopenia (ITP)
6. Ilumya tildrakizumab 3/20/2018 To treat adults with moderate-to-

severe plaque psoriasis who are
candidates for systemic therapy
or phototherapy
5. Trogarzo ibalizumab-uiyk 3/6/2018 To treat HIV patients who have

limited treatment options
4. Erleada apalutamide 2/14/2018 To treat a certain type of

prostate cancer using novel
clinical trial endpoint
Press Release
3. Symdeko tezacaftor; 2/13/2018 To treat cystic fibrosis in patients

ivacaftor age 12 years and older
Drug Trials Snapshot
2. Biktarvy bictegravir, 2/7/2018 To treat infection in adults who

embitcitabine, have no antiretroviral treatment
tenofovir history or to replace the current
alafenamide antiretroviral regimen
Drug Trials Snapshot
1. lutetium Lu 177 1/26/2018 To treat a type of cancer that

dotatate affects the pancreas or
gastrointestinal tract called
gastroenteropancreatic
neuroendocrine tumors (GEP-
NETs).
NEW DRUGS APPROVED BY US FDA IN 2017 [01 TO 46]
46. Giapreza angiotensin II 12/21/2017 To increase blood pressure in adults

with septic or other distributive shock
45. Macrilen macimorelin acetate 12/20/2017 For the diagnosis of adult growth
hormone deficiency
44. Steglatro ertugliflozin 12/19/2017 To improve glycemic control in adults with

type 2 diabetes mellitus
43. Rhopressa netarsudil 12/18/2017 To treat glaucoma or ocular

hypertension
42. Xepi ozenoxacin 12/11/2017 To treat impetigo
41. Ozempic semaglutide 12/5/2017 To improve glycemic control in adults

with type 2 diabetes mellitus
39. Mepsevii vestronidase alfa- 11/15/2017 To treat pediatric and adult patients
vjbk with an inherited metabolic condition
called mucopolysaccharidosis type
VII (MPS VII), also known as Sly
syndrome.
38. Fasenra benralizumab 11/14/2017 For add-on maintenance treatment of

patients with severe asthma aged 12
years and older, and with an
eosinophilic phenotype
37. Prevymis letermovir 11/8/2017 To prevent infection after bone

marrow transplant
36. Vyzulta latanoprostene 11/2/2017 To treat intraocular pressure in

bunod ophthalmic patients with open-angle glaucoma or
solution ocular hypertension.
35. Calquence acalabrutinib 10/31/2017 To treat adults with mantle cell

lymphoma
Verzenio abemaciclib 9/28/2017 To treat certain advanced or

34. metastatic breast cancers
33. Solosec secnidazole 9/15/2017 To treat bacterial vaginosis
32. Aliqopa copanlisib 9/14/2017 To treat adults with relapsed follicular

lymphoma
31. benznidazole benznidazole 8/29/2017 To treat children ages 2 to 12 years
old with Chagas disease
30. Vabomere meropenem and 8/29/2017 To treat adults with complicated

vaborbactam urinary tract infections
29. Besponsa inotuzumab 8/17/2017 To treat adults with relapsed or

ozogamicin refractory acute lymphoblastic
leukemia
28. Mavyret glecaprevir and 8/3/2017 To treat adults with chronic hepatitis
pibrentasvir C virus
27. Idhifa enasidenib 8/1/2017 To treat relapsed or refractory acute

myeloid leukemia
26. Vosevi sofosbuvir, 7/18/2017 To treat adults with chronic hepatitis

velpatasvir and C virus
voxilaprevir
25. Nerlynx neratinib maleate 7/17/2017 To reduce the risk of breast cancer
returning
24. Tremfya guselkumab 7/13/2017 For the treatment of adult patients

with moderate-to-severe plaque
psoriasis
t
23. Bevyxxa betrixaban 6/23/2017 For the prophylaxis of venous

thromboembolism (VTE) in adult
patients hospitalized for an acute
medical illness
22. Baxdela delafloxacin 6/19/2017 To treat patients with acute bacterial

skin infections
21. Kevzara sarilumab 5/22/2017 To treat adult rheumatoid arthritis

20. Radicava edaravone 5/5/2017 To treat patients with amyotrophic
lateral sclerosis (ALS)
19. Imfinzi durvalumab 5/1/2017 To treat patients with locally

advanced or metastatic urothelial
carcinoma
18. Tymlos abaloparatide 4/28/2017 To treat osteoporosis in

postmenopausal women at high risk
of fracture or those who have failed
other therapies
17. Rydapt midostaurin 4/28/2017 To treat acute myeloid leukemia
16. Alunbrig brigatinib 4/28/2017 To treat patients with anaplastic

lymphoma kinase (ALK)-positive
metastatic non-small cell lung cancer
(NSCLC) who have progressed on or
are intolerant to crizotinib
15. Brineura cerliponase alfa 4/27/2017 To treat a specific form of Batten

disease
14. Ingrezza valbenazine 4/11/2017 To treat adults with tardive

dyskinesia
13. Austedo deutetrabenazine 4/3/2017 For the treatment of chorea

associated with Huntington’s disease
12. Ocrevus ocrelizumab 3/28/2017 To treat patients with relapsing and

primary progressive forms of multiple
sclerosis
11. Dupixent dupilumab 3/28/2017 To treat adults with moderate-to-

severe eczema (atopic dermatitis)
10. Zejula niraparib 3/27/2017 For the maintenance treatment for

recurrent epithelial ovarian, fallopian
tube or primary peritoneal cancers
9. Symproic naldemedine 3/23/2017 For the treatment of opioid-induced

constipation
8. Bavencio avelumab 3/23/2017 To treat metastatic Merkel cell

carcinoma
7. Xadago safinamide 3/21/2017 To treat Parkinson’s disease
6. Kisqali ribociclib 3/13/2017 To treat postmenopausal women with

a type of advanced breast cancer
5. Xermelo telotristat ethyl 2/28/2017 To treat carcinoid syndrome diarrhea
4. Siliq brodalumab 2/15/2017 To treat adults with moderate-to-

severe plaque psoriasis
3. Emflaza deflazacort 2/9/2017 To treat patients age 5 years and

older with Duchenne muscular
dystrophy (DMD)
2. Parsabiv etelcalcetide 2/7/2017 To treat secondary

hyperparathyroidism in adult patients
with chronic kidney disease
undergoing dialysis
1. Trulance plecanatide 1/19/2017 To treat Chronic Idiopathic

Constipation (CIC) in adult patients.
2016 NEW DRUGS APPROVED BY US FDA [01 TO 26]
22. Spinraza nusinersen 12/23/2016 To treat children and adults with spinal muscular
atrophy (SMA)
To treat women with a certain type of ovarian

21. Rubraca rucaparib 12/19/2016 cancer
20. Eucrisa crisaborole 12/14/2016 To treat mild to moderate eczema (atopic dermatitis)
in patients two years of age and older
19. Zinplava bezlotoxumab 10/21/2016 To reduce the recurrence of Clostridium difficile

infection in patients aged 18 years or older
18. Lartruvo olaratumab 10/19/2016 To treat adults with certain types of soft tissue
sarcoma
17. Exondys eteplirsen 9/19/2016 To treat patients with Duchenne muscular

51 dystrophy
16. Adlyxin lixisenatide 7/27/2016 To improve glycemic control (blood sugar levels)
15. Xiidra lifitegrast 7/11/2016 To treat the signs and symptoms of dry eye disease
ophthalmic
solution
14. Epclusa sofosbuvir and 6/28/2016 To treat all six major forms of hepatitis C virus
velpatasvir
13. NETSPOT gallium Ga 68 6/1/2016 A diagnostic imaging agent to detect rare

dotatate neuroendocrine tumors
12. Axumin fluciclovine F 18 5/27/2016 A new diagnostic imaging agent to detect recurrent
prostate cancer
11. Ocaliva obeticholic acid 5/27/2016 To treat rare, chronic liver disease
10. Zinbryta daclizumab 5/27/2016 To treat multiple sclerosis
9. Tecentriq atezolizumab 5/18/2016 To treat urothelial carcinoma, the most common

type of bladder cancer
8. Nuplazid pimavanserin 4/29/2016 To treat hallucinations and delusions associated

with psychosis experienced by some people with
Parkinson’s disease
7. Venclexta venetoclax 4/11/2016 For chronic lymphocytic leukemia in patients with a

specific chromosomal abnormality
6. Defitelio defibrotide 3/30/3016 To treat adults and children who develop hepatic
sodium veno-occlusive disease with additional kidney or
lung abnormalities after they receive a stem cell
transplant from blood or bone marrow called
hematopoietic stem cell transplantation
5. Cinqair reslizumab 3/23/2016 To treat severe asthma
4. Taltz ixekizumab 3/22/2016 To treat adults with moderate-to-severe plaque

psoriasis.
3. Anthim obiltoxaximab 3/18/2016 To treat inhalational anthrax in combination with
appropriate antibacterial drugs.
2. Briviact brivaracetam 2/18/2016 To treat partial onset seizures in patients age 16

years and older with epilepsy.
1. Zepatier elbasvir and 1/28/2016 To treat patients with chronic hepatitis C virus
grazoprevir (HCV) genotypes 1 and 4 infections in adult
patients.
2015 NEW DRUGS APPROVED BY US FDA [01 TO 45]
45. Zurampic lesinurad 12/22/2015 To treat high blood uric acid levels
associated with gout
44. Uptravi selexipag 12/22/2015 To treat pulmonary arterial hypertension
To reverse effects of neuromuscular

43. Bridion sugammadex 12/15/2015 blocking drugs used during surgery
42. Alecensa alectinib 12/11/2015 To treat ALK-positive lung cancer
41. Kanuma sebelipase alfa 12/8/2015 To treat patients with a rare disease
known as lysosomal acid lipase (LAL)
deficiency
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
38. Ninlaro ixazomib 11/20/2015 To treat people with multiple myeloma

who have received at least one prior
therapy
37. Darzalex daratumumab 11/16/2015 To treat patients with multiple myeloma

who have received at least three prior
treatments.
36. Tagrisso osimertinib 11/13/2015 To treat certain patients with non-small

cell lung cancer
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)
34. Genvoya a fixed-dose combination 11/5/2015 For use as a complete regimen for the
tablet containing treatment of HIV-1 infection in adults and
elvitegravir, cobicistat, pediatric patients 12 years of age and
emtricitabine, and older
tenofovir alafenamide
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.
32. Strensiq asfotase alfa 10/23/2015 To treat perinatal, infantile and juvenile-
onset hypophosphatasia (HPP).
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).
30. Veltassa patiromer for oral 10/21/2015 To treat hyperkalemia, a serious condition
suspension in which the amount of potassium in the
blood is too high.
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.
28. Aristada aripiprazole lauroxil 10/6/2015 To treat adults with schizophrenia
27. Tresiba insulin degludec injection 9/25/2015 To improve blood sugar (glucose) control
in adults with diabetes mellitus
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
25. Vraylar cariprazine 9/17/2015 To treat schizophrenia and bipolar

disorder in adults
24. Xuriden uridine triacetate 9/4/2015 To treat patients with hereditary orotic
aciduria
23. Varubi rolapitant 9/2/2015 To prevent delayed phase chemotherapy-

induced nausea and vomiting (emesis)
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
20. Daklinza daclatasvir 7/24/2015 To treat chronic hepatitis C virus (HCV)

genotype 3 infections
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.
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
16. Entresto sacubitril/valsartan 7/7/2015 To treat heart failure
15. Orkambi lumacaftor 200 7/2/2015 To treat cystic fibrosis

mg/ivacaftor 125 mg
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
13. Viberzi eluxadoline 5/27/2015 To treat irritable bowel syndrome with

diarrhea (IBS-D) in adult men and
women.
12. Kybella deoxycholic acid 4/29/2015 To treat adults with moderate-to-severe

fat below the chin, known as submental
fat
11. Corlanor ivabradine 4/15/2015 To reduce hospitalization from worsening

heart failure.
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
9. Unituxin dinutuximab 3/10/2015 To treat pediatric patients with high-risk

neuroblastoma
8. Cresemba isavuconazonium sulfate 3/6/2015 To treat adults with invasive aspergillosis

capsule and invasive mucormycosis, rare but
injection serious infections
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.
6. Farydak panobinostat 2/23/2015 To treat patients with multiple myeloma
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).
4. Ibrance palbociclib 2/3/2015 To treat advanced (metastatic) breast

cancer
3. Natpara parathyroid horomone 1/23/2015 To control hypocalcemia (low blood

calcium levels) in patients with
hypoparathyroidism
2. Cosentyx secukinumab 1/21/2015 To treat adults with moderate-to-severe

plaque psoriasis
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
2014
2014 FDA Approved Drugs

Cardiology/Vascular Diseases
Epanova (omega-3-carboxylic acids); AstraZeneca; For the treatment of severe hypertriglyceridemia,
Approved May 2014
Zontivity (vorapaxar); Merck; For the reduction of thrombotic cardiovascular events, Approved May 2014
Dermatology
Dalvance (dalbavancin); Durata Therapeutics; For the treatment of acute bacterial skin and skin structure
infections, Approved May 2014
Jublia (efinaconazole) 10% topical gel; Valeant Pharmaceuticals; For the treatment of onychomycosis of
the toenails, Approved June 2014
Kerydin (tavaborole); Anacor; For the treatment of onychomycosis of the toenails, Approved July 2014
Keytruda (pembrolizumab); Merck; For the treatment of unresectable or metastatic melanoma, Approved
September 2014
Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of unresectable or metastatic melanoma,
Approved December 2014
Orbactiv (oritavancin); The Medicines Company; For the treatment of acute bacterial skin and skin
structure infections, Approved August 2014
Otezla (apremilast); Celgene; For the treatment of moderate to severe plaque psoriasis, Approved
September 2014
Sivextro (tedizolid phosphate) ; Cubist Pharmaceuticals; For the treatment of acute bacterial skin and
skin structure infections, Approved June 2014
Soolantra (ivermectin) cream, 1%; Galderma Labs; For the treatment of inflammatory lesions of rosacea,
Endocrinology
Afrezza (insulin human) Inhalation Powder; Mannkind; For the treatment of diabetes mellitus, Approved
June 2014
Aveed (testosterone undecanoate) injection; Endo Pharmaceuticals; For the treatment of
hypogonadism, Approved March 2014
Eylea (aflibercept); Regeneron Pharmaceuticals; For the treatment of diabetic macular edema, Approved
July 2014
Farxiga (dapagliflozin); Bristol-Myers Squibb; For the treatment of type II diabetes, January of 2014
Jardiance (empagliflozin) ; Boehringer Ingelheim; For the treatment of type II diabetes, Approved August
2014
Natesto, (testosterone) nasal gel; Trimel Pharmaceuticals; For the treatment of deficiency or absence of
endogenous testosterone, Approved May 2014
Signifor LAR (pasireotide); Novartis; For the treatment of acromegaly, Approved December 2014
Tanzeum (albiglutide); GlaxoSmithKline; For the treatment of type II diabetes mellitus, Approved April
2014
Trulicity (dulaglutide); Eli Lilly; To improve glycemic control in type II diabetics, Approved September
2014
Vogelxo (testosterone) gel; Upsher-Smith; For males with a deficiency or absence of endogenous
testosterone, Approved June 2014
Xigduo XR (dapagliflozin + metformin hydrochloride); AstraZeneca; For glycemic control in adults with
type II diabetes, Approved October 2014
Family Medicine
Afrezza (insulin human) Inhalation Powder; Mannkind; For the treatment of diabetes mellitus, Approved
June 2014
Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec; For the treatment of
hemophilia B, Approved March 2014
Arnuity Ellipta (fluticasone furoate inhalation powder); GlaxoSmithKline; For the treatment of asthma,
Approved August 2014
Aveed (testosterone undecanoate) injection; Endo Pharmaceuticals; For the treatment of
hypogonadism, Approved March 2014
Belsomra (suvorexant); Merck; For the treatment of insomnia, Approved August 2014
Bunavail (buprenorphine and naloxone); BioDelivery Sciences; For the maintenance treatment of opioid
dependence, Approved June 2014
Contrave (naltrexone HCl and bupropion HCl) ; Takeda Pharmaceuticals U.S.A.; For chronic weight
management , Approved September 2014
Dyloject (diclofenac sodium) Injection; Hospira; For the management of mild, moderate or severe pain,
Entyvio (vedolizumab); Millenium Pharmaceuticals; For the treatment of adults with ulcerative colitis and
Crohn's disease, Approved May of 2014
Farxiga (dapagliflozin); Bristol-Myers Squibb; For the treatment of type II diabetes, January of 2014
Grastek (Timothy Grass Pollen Allergen Extract); Merck; For the treatment of grass pollen-induced
allergic rhinitis, Approved April 2014
2014
Metronidazole 1.3% Vaginal Gel; Actavis, Inc.; For the treatment of bacterial vaginosis, Approved April
2014
Myalept (metreleptin for injection); Bristol-Myers Squibb; For the treatment of congenital or acquired
generalized lipodystrophy, Approved February of 2014
Natesto, (testosterone) nasal gel; Trimel Pharmaceuticals; For the treatment of deficiency or absence of
endogenous testosterone, Approved May 2014
Northera (droxidopa); Chelsea Therapeutics; For the treatment of neurogenic orthostatic hypotension,
Approved February 2014
Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens
Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without
conjunctivitis, Approved April 2014
Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March
2014
September 2014
Plegridy (peginterferon beta-1a); Biogen IDEC.; For the treatment of relapsing multiple sclerosis,
Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary
generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014
Ragwitek (Short Ragweed Pollen Allergen Extract); Merck; For the treatment of short ragweed pollen-
induced allergic rhinitis, Approved April 2014
Rapivab (peramivir injection); Biocryst; For the treatment of acute uncomplicated influenza in adults,
Saxenda (liraglutide [rDNA origin] injection); Novo Nordisk; For chronic weight management, Approved
December 2014
2014
Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets; Purdue
Pharma; For the management of severe chronic pain, Approved July 2014
Tivorbex (indomethacin); Iroko Pharmaceuticals; For the treatment of acute pain, Approved February of
2014
2014
Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release; Mallinckrodt
Pharmaceuticals; For the management of acute pain, Approved March 2014
Xtoro (finafloxacin otic suspension) 0.3%; Alcon; For the treatment of acute otitis externa, Approved
December 2014
Zerbaxa (ceftolozane + tazobactam) ; Cubist Pharmaceuticals; For the treatment of complicated intra-
abdominal and urinary tract infections, Approved December 2014
Gastroenterology
Akynzeo (netupitant and palonosetron); Helsinn; For the prevention of chemotherapy-induced nausea
and vomiting, Approved October 2014
Cyramza (ramucirumab); Eli Lilly; For the treatment of gastric cancer, Approved April 2014
Movantik (naloxegol); AstraZeneca; For the treatment of opiod-induced constipation in adults with chronic
non-cancer pain, Approved September 2014
Genetic Disease
Cerdelga (eliglustat); Genzyme; For the treatment of certain adult patients with Gaucher disease type 1,
Vimizim (elosulfase alfa); BioMarin; For the treatment of Mucopolysaccharidosis type IVA, Approved
February 2014
Healthy Volunteers
Hematology
Beleodaq (belinostat); Spectrum Pharmaceuticals; For the treatment of relapsed or refractory peripheral
T-cell lymphoma, Approved July 2014
Blincyto (blinatumomab); Amgen; For the treatment of Philadelphia chromosome-negative relapsed
/refractory B cell precursor acute lymphoblastic leukemia, Approved December 2014
Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] ; Biogen IDEC.; For the treatment
of hemophillia A, Approved June 2014
Imbruvica (ibrutinib); Pharmacyclics; For the treatment of chronic lymphocytic leukemia and small
lymphocytic lymphoma, Approved February 2014
Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence]; Baxter; For the treatment of
acquired hemophilia A, Approved October 2014
Ruconest (C1 esterase inhibitor [recombinant]); Pharming Group; For the treatment of hereditary
angioedema, Approved July 2014
Sylvant (siltuximab); Janssen Biotech; For the treatment of multicentric Castleman’s disease, Approved
April 2014
Zontivity (vorapaxar); Merck; For the reduction of thrombotic cardiovascular events, Approved May 2014
Zydelig (idelalisib); Gilead; For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic
lymphoma, Approved July 2014
Immunology
HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]; Baxter;
For the treatment of Primary Immunodeficiency, Approved September 2014
Incruse Ellipta (umeclidinium inhalation powder); GlaxoSmithKline; For the treatment of chronic
obstructive pulmonary disease, Approved May 2014
2014
September 2014
Sylvant (siltuximab); Janssen Biotech; For the treatment of multicentric Castleman’s disease, Approved
April 2014
Triumeq (abacavir, dolutegravir, and lamivudine); ViiV HealthCare; For the treatment of HIV-1,
Infections and Infectious Diseases

Harvoni (ledipasvir and sofosbuvir); Gilead; For the treatment of hepatitis C, Approved October 2014
Impavido (miltefosine); Knight Therapeutics; For the treatment of visceral, cutaneous and mucosal
leishmaniasis, Approved March 2014
Jublia (efinaconazole) 10% topical gel; Valeant Pharmaceuticals; For the treatment of onychomycosis of
the toenails, Approved June 2014
2014
Orbactiv (oritavancin); The Medicines Company; For the treatment of acute bacterial skin and skin
structure infections, Approved August 2014
Rapivab (peramivir injection); Biocryst; For the treatment of acute uncomplicated influenza in adults,
Sivextro (tedizolid phosphate) ; Cubist Pharmaceuticals; For the treatment of acute bacterial skin and
skin structure infections, Approved June 2014
Triumeq (abacavir, dolutegravir, and lamivudine); ViiV HealthCare; For the treatment of HIV-1,
Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) tablets; Abbvie; For the treatment of
genotype 1 chronic hepatitis C virus, Approved December 2014
December 2014
Internal Medicine
Cerdelga (eliglustat); Genzyme; For the treatment of certain adult patients with Gaucher disease type 1,
Musculoskeletal
Lemtrada (alemtuzumab); Genzyme; For the treatment of relapsing multiple sclerosis, Approved
November 2014
2014
February 2014
Nephrology
Auryxia (Ferric citrate); Keryx Biopharma; For the treatment of hyperphosphatemia in patients with
chronic kidney disease, Approved September 2014
Harvoni (ledipasvir and sofosbuvir); Gilead; For the treatment of hepatitis C, Approved October 2014
Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) tablets; Abbvie; For the treatment of
genotype 1 chronic hepatitis C virus, Approved December 2014
Neurology
Belsomra (suvorexant); Merck; For the treatment of insomnia, Approved August 2014
Dyloject (diclofenac sodium) Injection; Hospira; For the management of mild, moderate or severe pain,
Hetlioz (tasimelteon); Vanda Pharmaceuticals; For the treatment of non-24-hour sleep-wake disorder in
the totally blind, January 2014
Lemtrada (alemtuzumab); Genzyme; For the treatment of relapsing multiple sclerosis, Approved
November 2014
Namzaric (memantine hydrochloride extended-release + donepezil hydrochloride); Forest
Laboratories; For the treatment of moderate to severe dementia of the Alzheimer's type, Approved
December 2014
Northera (droxidopa); Chelsea Therapeutics; For the treatment of neurogenic orthostatic hypotension,
Approved February 2014
Tivorbex (indomethacin); Iroko Pharmaceuticals; For the treatment of acute pain, Approved February of
2014
Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release; Mallinckrodt
Pharmaceuticals; For the management of acute pain, Approved March 2014
Nutrition and Weight Loss

Contrave (naltrexone HCl and bupropion HCl) ; Takeda Pharmaceuticals U.S.A.; For chronic weight
management , Approved September 2014
2014
Saxenda (liraglutide [rDNA origin] injection); Novo Nordisk; For chronic weight management, Approved
December 2014
2014
2014
Obstetrics/Gynecology (Women’s Health)

Avastin (bevacizumab); Genentech; For the treatment of persistent, recurrent, or metastatic cervical
cancer, Approved August 2014
Avastin (bevacizumab); Genentech; For the treatment of stage III or IV epithelial ovarian, fallopian tube,
or primary peritoneal cancer , Approved November 2014
Lynparza (olaparib); AstraZeneca; For the treatment of previously treated BRCA mutated advanced
ovarian cancer, Approved December 2014
2014
Oncology
Avastin (bevacizumab); Genentech; For the treatment of stage III or IV epithelial ovarian, fallopian tube,
or primary peritoneal cancer , Approved November 2014
Avastin (bevacizumab); Genentech; For the treatment of persistent, recurrent, or metastatic cervical
cancer, Approved August 2014
Beleodaq (belinostat); Spectrum Pharmaceuticals; For the treatment of relapsed or refractory peripheral
T-cell lymphoma, Approved July 2014
Blincyto (blinatumomab); Amgen; For the treatment of Philadelphia chromosome-negative relapsed
/refractory B cell precursor acute lymphoblastic leukemia, Approved December 2014
Cyramza (ramucirumab); Eli Lilly; For the treatment of gastric cancer, Approved April 2014
Imbruvica (ibrutinib); Pharmacyclics; For the treatment of chronic lymphocytic leukemia and small
lymphocytic lymphoma, Approved February 2014
Keytruda (pembrolizumab); Merck; For the treatment of unresectable or metastatic melanoma, Approved
September 2014
Lynparza (olaparib); AstraZeneca; For the treatment of previously treated BRCA mutated advanced
ovarian cancer, Approved December 2014
Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of unresectable or metastatic melanoma,
Zydelig (idelalisib); Gilead; For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic
lymphoma, Approved July 2014
Zykadia (ceritinib); Novartis; For the treatment of ALK+ metastatic non-small cell lung cancer, Approved
April 2014
Ophthalmology
Eylea (aflibercept); Regeneron Pharmaceuticals; For the treatment of diabetic macular edema, Approved
July 2014
Omidria (phenylephrine and ketorolac injection); Omeros; For use during eye surgery to prevent
intraoperative miosis and reduce post-operative pain, Approved June 2014
Orthopedics/Orthopedic Surgery
2014
Otolaryngology (Ear, Nose, Throat)

December 2014
Pediatrics/Neonatology
February 2014
Pharmacology/Toxicology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Esbriet (pirfenidone); InterMune; For the treatment of idiopathic pulmonary fibrosis , Approved October
2014
Incruse Ellipta (umeclidinium inhalation powder); GlaxoSmithKline; For the treatment of chronic
obstructive pulmonary disease, Approved May 2014
Ofev (nintedanib); Boehringer Ingelheim; For the treatment of idiopathic pulmonary fibrosis , Approved
October 2014
Striverdi Respimat (olodaterol); Boehringer Ingelheim; For the treatment of chronic obstructive
pulmonary disease , Approved July 2014
Zykadia (ceritinib); Novartis; For the treatment of ALK+ metastatic non-small cell lung cancer, Approved
April 2014
Rheumatology
2014
Sleep
Urology
This document PAGES 01 TO 28 has been compiled from the US FDA Website for NEW DRUG
APPROVALS from 2014 to 2018 by
Dr Prem R Goel
BPharm[Nagpur]MPharm[Mumbai]
MS,PhD[USA] MBA[USA]MIQA[UK]
+91 7600135939
goelngoelassociatesplc
drpremrgoel@gmail.com
NOT FOR COMMERCIAL USE

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New Drugs 2014-2018

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NEW DRUGS 2018 01 TO 59

59 Ultomiris 12/21/2018 To treat paroxysmal nocturnal

58. Elzonris tagraxofusp-erzs 12/21/2018 To treat blastic plasmacytoid

57. Asparlas calaspargase 12/20/2018 To treat acute lymphoblastic

56. Motegrity prucalopride 12/14/2018 To treat chronic idiopathic

55. Xospata gilteritinib 11/28/2018 To treat patients who have

54. Firdapse amifampridine 11/28/2018 To treat Lambert-Eaton

52. Daurismo glasdegib 11/21/2018 To treat newly-diagnosed acute

51. Gamifant emapalumab- 11/20/2018 To treat primary hemophagocytic

50. Aemcolo rifamycin 11/16/2018 To treat travelers’ diarrhea

49. Yupelri revefenacin 11/8/2018 To treat patients with chronic

48. Lorbrena lorlatinib 11/2/2018 To treat patients with anaplastic

For the treatment of locally

45. Tegsedi inotersen 10/5/2018 To treat polyneuropathy of

44. Revcovi elapegademase- 10/5/2018 To treat Adenosine Deaminase-

43. Nuzyra omadacycline 10/3/2018 To treat community-acquired

42. Seysara sarecycline 10/1/2018 To treat inflammatory lesions of

41. Libtayo cemiplimab-rwlc 9/28/2018 To treat cutaneous squamous

40. Vizimpro dacomitinib 9/27/2018 To treat metastatic non-small-

39. Emgality galcanezumab- 9/27/2018 For the preventive treatment of

38 Copiktra duvelisib 9/24/2018 To treat relapsed or refractory

37. Ajovy fremanezumab- 9/14/2018 For the preventive treatment of

36. Lumoxiti moxetumomab 9/13/2018 To treat hairy cell leukemia

35. Pifeltro doravirine 8/30/2018 To treat HIV-1 infection in adult

34. Xerava eravacycline 8/27/2018 To treat complicated intra-

33. Takhzyro lanadelumab 8/23/2018 To treat types I and II hereditary

32. Oxervate cenegermin-bkbj 8/22/2018 To treat neurotrophic keratitis

31. Diacomit stiripentol 8/20/2018 To treat seizures associated with

30. Galafold migalastat 8/10/2018 To treat treat adults with Fabry

29. Annovera segesterone 8/10/2018 New vaginal ring used to prevent

28. Onpattro patisiran 8/10/2018 To treat the polyneuropathy of

26. Mulpleta lusutrombopag 7/31/2018 To treat thrombocytopenia in

25. Omegaven fish oil 7/27/2018 As a source of calories and fatty

24. Orilissa elagolix sodium 7/23/2018 For the management of

23. Krintafel tafenoquine 7/20/2018 For the radical cure (prevention

22. Tibsovo ivosidenib 7/20/2018 To treat patients with relapsed or

21. TPOXX tecovirimat 7/13/2018 To treat smallpox

20. Braftovi encorafenib 6/27/2018 To treat unresectable or

19. Mektovi binimetinib 6/27/2018 To treat unresectable or

18. Zemdri plazomicin 6/25/2018 To treat adults with complicated

17. Epidiolex cannabidiol 6/25/2018 To treat rare, severe forms of

15. Olumiant baricitinib 5/31/2018 To treat moderately to severely

14. Palynziq pegvaliase-pqpz 5/24/2018 To treat adults with a rare and

13. Doptelet avatrombopag 5/21/2018 To treat low blood platelet count

12. Lokelma sodium 5/18/2018 To treat hyperkalemia

11. Aimovig erenumab-aooe 5/17/2018 For the preventive treatment for

10. Lucemyra lofexidine 5/16/2018 For the non-opioid treatment for

9. Akynzeo fosnetupitant and 4/19/2018 To prevent acute and delayed

8. Crysvita burosumab-twza 4/17/2018 To treat adults and children ages

7. Tavalisse fostamatinib 4/17/2018 To treat thrombocytopenia in

6. Ilumya tildrakizumab 3/20/2018 To treat adults with moderate-to-

5. Trogarzo ibalizumab-uiyk 3/6/2018 To treat HIV patients who have

4. Erleada apalutamide 2/14/2018 To treat a certain type of

3. Symdeko tezacaftor; 2/13/2018 To treat cystic fibrosis in patients

2. Biktarvy bictegravir, 2/7/2018 To treat infection in adults who

1. lutetium Lu 177 1/26/2018 To treat a type of cancer that

46. Giapreza angiotensin II 12/21/2017 To increase blood pressure in adults

44. Steglatro ertugliflozin 12/19/2017 To improve glycemic control in adults with

43. Rhopressa netarsudil 12/18/2017 To treat glaucoma or ocular

42. Xepi ozenoxacin 12/11/2017 To treat impetigo

41. Ozempic semaglutide 12/5/2017 To improve glycemic control in adults

38. Fasenra benralizumab 11/14/2017 For add-on maintenance treatment of

37. Prevymis letermovir 11/8/2017 To prevent infection after bone

36. Vyzulta latanoprostene 11/2/2017 To treat intraocular pressure in

35. Calquence acalabrutinib 10/31/2017 To treat adults with mantle cell

Verzenio abemaciclib 9/28/2017 To treat certain advanced or