Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
APPROVED BY
US FDA
NEW DRUGS
2018 US FDA [01 TO 59]
45. Macrilen macimorelin acetate 12/20/2017 For the diagnosis of adult growth
hormone deficiency
28. Mavyret glecaprevir and 8/3/2017 To treat adults with chronic hepatitis
pibrentasvir C virus
25. Nerlynx neratinib maleate 7/17/2017 To reduce the risk of breast cancer
returning
22. Spinraza nusinersen 12/23/2016 To treat children and adults with spinal muscular
atrophy (SMA)
20. Eucrisa crisaborole 12/14/2016 To treat mild to moderate eczema (atopic dermatitis)
in patients two years of age and older
18. Lartruvo olaratumab 10/19/2016 To treat adults with certain types of soft tissue
sarcoma
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
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
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
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.
45. Zurampic lesinurad 12/22/2015 To treat high blood uric acid levels
associated with gout
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
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).
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.
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
24. Xuriden uridine triacetate 9/4/2015 To treat patients with hereditary orotic
aciduria
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
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,
Approved December 2014
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
Dalvance (dalbavancin); Durata Therapeutics; For the treatment of acute bacterial skin and skin structure
infections, Approved May 2014
Dyloject (diclofenac sodium) Injection; Hospira; For the management of mild, moderate or severe pain,
Approved December 2014
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
Jardiance (empagliflozin) ; Boehringer Ingelheim; For the treatment of type II diabetes, Approved August
2014
Kerydin (tavaborole); Anacor; For the treatment of onychomycosis of the toenails, Approved July 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
Otezla (apremilast); Celgene; For the treatment of moderate to severe plaque psoriasis, Approved
September 2014
Plegridy (peginterferon beta-1a); Biogen IDEC.; For the treatment of relapsing multiple sclerosis,
Approved August 2014
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,
Approved December 2014
Saxenda (liraglutide [rDNA origin] injection); Novo Nordisk; For chronic weight management, Approved
December 2014
Tanzeum (albiglutide); GlaxoSmithKline; For the treatment of type II diabetes mellitus, Approved April
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
Trulicity (dulaglutide); Eli Lilly; To improve glycemic control in type II diabetics, Approved September
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
Entyvio (vedolizumab); Millenium Pharmaceuticals; For the treatment of adults with ulcerative colitis and
Crohn's disease, Approved May of 2014
Movantik (naloxegol); AstraZeneca; For the treatment of opiod-induced constipation in adults with chronic
non-cancer pain, Approved September 2014
Zerbaxa (ceftolozane + tazobactam) ; Cubist Pharmaceuticals; For the treatment of complicated intra-
abdominal and urinary tract infections, Approved December 2014
Genetic Disease
Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec; For the treatment of
hemophilia B, Approved March 2014
Cerdelga (eliglustat); Genzyme; For the treatment of certain adult patients with Gaucher disease type 1,
Approved August 2014
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
Vimizim (elosulfase alfa); BioMarin; For the treatment of Mucopolysaccharidosis type IVA, Approved
February 2014
Healthy Volunteers
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
Hematology
Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec; For the treatment of
hemophilia B, Approved March 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
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
Entyvio (vedolizumab); Millenium Pharmaceuticals; For the treatment of adults with ulcerative colitis and
Crohn's disease, Approved May of 2014
Grastek (Timothy Grass Pollen Allergen Extract); Merck; For the treatment of grass pollen-induced
allergic rhinitis, Approved April 2014
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
Myalept (metreleptin for injection); Bristol-Myers Squibb; For the treatment of congenital or acquired
generalized lipodystrophy, Approved February of 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
Otezla (apremilast); Celgene; For the treatment of moderate to severe plaque psoriasis, Approved
September 2014
Plegridy (peginterferon beta-1a); Biogen IDEC.; For the treatment of relapsing multiple sclerosis,
Approved August 2014
Ragwitek (Short Ragweed Pollen Allergen Extract); Merck; For the treatment of short ragweed pollen-
induced allergic rhinitis, Approved April 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,
Approved August 2014
Internal Medicine
Cerdelga (eliglustat); Genzyme; For the treatment of certain adult patients with Gaucher disease type 1,
Approved August 2014
Musculoskeletal
Lemtrada (alemtuzumab); Genzyme; For the treatment of relapsing multiple sclerosis, Approved
November 2014
Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March
2014
Plegridy (peginterferon beta-1a); Biogen IDEC.; For the treatment of relapsing multiple sclerosis,
Approved August 2014
Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets; Purdue
Pharma; For the management of severe chronic pain, Approved July 2014
Vimizim (elosulfase alfa); BioMarin; For the treatment of Mucopolysaccharidosis type IVA, Approved
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,
Approved December 2014
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
Movantik (naloxegol); AstraZeneca; For the treatment of opiod-induced constipation in adults with chronic
non-cancer pain, Approved September 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
Plegridy (peginterferon beta-1a); Biogen IDEC.; For the treatment of relapsing multiple sclerosis,
Approved August 2014
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
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
Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release; Mallinckrodt
Pharmaceuticals; For the management of acute pain, Approved March 2014
Oncology
Akynzeo (netupitant and palonosetron); Helsinn; For the prevention of chemotherapy-induced nausea
and vomiting, Approved October 2014
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,
Approved December 2014
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
Hetlioz (tasimelteon); Vanda Pharmaceuticals; For the treatment of non-24-hour sleep-wake disorder in
the totally blind, January 2014
Omidria (phenylephrine and ketorolac injection); Omeros; For use during eye surgery to prevent
intraoperative miosis and reduce post-operative pain, Approved June 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
Orthopedics/Orthopedic Surgery
Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March
2014
Pediatrics/Neonatology
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
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
Vimizim (elosulfase alfa); BioMarin; For the treatment of Mucopolysaccharidosis type IVA, Approved
February 2014
Pharmacology/Toxicology
Akynzeo (netupitant and palonosetron); Helsinn; For the prevention of chemotherapy-induced nausea
and vomiting, Approved October 2014
Bunavail (buprenorphine and naloxone); BioDelivery Sciences; For the maintenance treatment of opioid
dependence, Approved June 2014
Movantik (naloxegol); AstraZeneca; For the treatment of opiod-induced constipation in adults with chronic
non-cancer pain, Approved September 2014
Myalept (metreleptin for injection); Bristol-Myers Squibb; For the treatment of congenital or acquired
generalized lipodystrophy, Approved February of 2014
Psychiatry/Psychology
Bunavail (buprenorphine and naloxone); BioDelivery Sciences; For the maintenance treatment of opioid
dependence, Approved June 2014
Pulmonary/Respiratory Diseases
Arnuity Ellipta (fluticasone furoate inhalation powder); GlaxoSmithKline; For the treatment of asthma,
Approved August 2014
Esbriet (pirfenidone); InterMune; For the treatment of idiopathic pulmonary fibrosis , Approved October
2014
Grastek (Timothy Grass Pollen Allergen Extract); Merck; For the treatment of grass pollen-induced
allergic rhinitis, Approved April 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
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
Ragwitek (Short Ragweed Pollen Allergen Extract); Merck; For the treatment of short ragweed pollen-
induced allergic rhinitis, Approved April 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
Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March
2014
Sleep
Hetlioz (tasimelteon); Vanda Pharmaceuticals; For the treatment of non-24-hour sleep-wake disorder in
the totally blind, January 2014
Urology
Zerbaxa (ceftolozane + tazobactam) ; Cubist Pharmaceuticals; For the treatment of complicated intra-
abdominal and urinary tract infections, Approved December 2014
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