New Drugs Approved By FDA In 2016

Following are some of the New Drugs Approved By FDA , We Have Highlighted Drugs,Their Category,Indications,Month of Approval and Manufacturers.

New Drugs Approved By FDA In 2016

Drugs And CategoryIndications/UsesDate Of ApprovalManufacturer
Musculoskeletal:
a)Exondys 51 (eteplirsen)
b)Spinraza (nusinersen)
c)Zinbryta (daclizumab)
a)For the treatment of Duchenne muscular dystrophy with mutated DMD gene amenable to exon 51 skipping
b)For the treatment of spinal muscular atrophy
c) For the treatment of relapsing multiple sclerosis
a)Approved September 2016
b)Approved December 2016
c)Approved May 2016
a)Sarepta Therapeutics
b)Biogen;
c)Biogen
Nephrology:
a)Cabometyx (cabozantinib)
b)Lenvima (lenvatinib
c)Rayaldee (calcifediol)
a) For the treatment of advanced renal cell carcinoma
b)For the treatment of advanced renal cell carcinoma
c) For the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease,
a) Approved April 2016
b) Approved May 2016
c)Approved June 2016
a)Exelixis
b)Eisai
c)Opko Health
Gastroenterology:
Zinplava (bezlotoxumab)
For the treatment of recurrent Clostridium difficile infection in patients receiving antibacterial treatment,Approved October 2016Merck
Genetic Disease:
Spinraza (nusinersen);
For the treatment of spinal muscular atrophy,Approved December 2016Biogen;
Hematology:
a)Afstyla (Antihemophilic Factor (Recombinant) Single Chain),
b)Idelvion (Coagulation Factor IX (Recombinant),Albumin Fusion Protein);
c)Kovaltry [Antihemophilic Factor (Recombinant)];
d)Opdivo (nivolumab);
e)Venclexta (venetoclax);
a)For the treatment of hemophillia A,
b)For the treatment of hemophilia B,
c)For the treatment of hemophillia A
d) For the treatment of classical Hodgkin lymphoma
e)For the treatment of chronic lymphocytic leukemia with 17p deletion
a)Approved May 2016
b)Approved March 2016
c)Approved March 2016
d)Approved May 2016
e)Approved April 2016
a) CSL Behring
b)CSL Behring;
c)Bayer
d)Bristol-Myers Squibb;
e)AbbVie
Hepatology (Liver, Pancreatic, Gall Bladder):
a)Defitelio (defibrotide sodium);
b)Ocaliva (obeticholic acid);
c)Vemlidy (tenofovir alafenamide);
d)Zepatier (elbasvir and grazoprevir)
a)For the treatment of hepatic veno-occlusive disease with renal or pulmonary dysfunction following HSC
b) For the treatment of primary biliary cholangitis
c)For the treatment of chronic hepatitis B
d)For the treatment of chronic HCV genotypes 1 or 4
a)Approved March 2016
b)Approved May 2016
c)Approved November 2016
d) Approved January 2016
a) Jazz Pharmaceuticals
b)Intercept Pharmaceuticals
c)Gilead Sciences
d)Merck;
Immunology:
a)Afstyla (Antihemophilic Factor(Recombinant), Single Chain); CSL
b)Descovy (emtricitabine and tenofovir alafenamide);
c)Epclusa (sofosbuvir and velpatasvir) ;
d)Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide);
e)Taltz (ixekizumab)
f)Vaxchora (Cholera Vaccine, Live, Oral);
a)For the treatment of hemophillia A,
b)For the treatment of HIV-1 infection,
c) For the treatment of hepatitis C,
d) For the treatment of HIV-1 as initial therapy,
e)For the treatment of plaque psoriasis,
f) For active immunization against Cholera,
a)Approved May 2016
b)Approved April 2016
c)Approved June 2016
d)Approved March 2016
e)Approved March 2016
f)Approved June 2016
a)CSLBehring;
b)Gilead Sciences
c)Gilead Sciences;
d)Gilead Sciences
e)Eli Lilly;
f)PaxVax;
Infections and Infectious Diseases:
a)Anthim (obiltoxaximab);
b)Descovy (emtricitabine and tenofovir alafenamide)
c)Epclusa (sofosbuvir and velpatasvir)
d)Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide)
e)Vemlidy (tenofovir alafenamide)
f)Zepatier (elbasvir and grazoprevir)
g)Zinplava (bezlotoxumab)
a)For the treatment of inhalational anthrax
b)For the treatment of HIV-1 infection
c)For the treatment of hepatitis C
d)For the treatment of HIV-1 as initial therapy
e)For the treatment of chronic hepatitis B
f)For the treatment of chronic HCV genotypes 1 or 4
g)For the treatment of recurrent Clostridium difficile infection in patients receiving antibacterial treatment
a)Approved March 2016
b)Approved April 2016
c)Approved June 2016
d)Approved March 2016
e)Approved November 2016
f) Approved January 2016
g)Approved October 2016
a)Elusys Therapeutics
b)Gilead
c)Gilead Sciences
d)Gilead Sciences
e)Gilead Sciences
f)Merck
g)Merck
Cardiology/Vascular Disease:
a)Byvalson (nebivolol and valsartan);

b)Yosprala (aspirin and omeprazole);
a)For the treatment of hypertension
b)For the prevention of cardiovascular and cerebrovascular events
a)Approved June 2016
b)Approved September 2016
a)Allergan
b)Aralez Pharmaceuticals
Family Medicine:
a)Byvalson (nebivolol and valsartan)
b)Onzetra Xsail (sumatriptan nasal powder)
c)Soliqua 100/33 (insulin glargine and lixisenatide injection)
d)Xultophy 100/3.6 (insulin degludec and liraglutide injection)
a)For the treatment of hypertension
b)For the treatment of migraine
c)For the treatment of inadequately controlled type II diabetes,
d)For the treatment of inadequately controlled type II diabetes
a)Approved June 2016
b)Approved January 2016
c)Approved November 2016
d) Approved November 2016
a)Allergan
b)Avanir
c)Sanofi Aventis
d)Novo Nordisk;
Vaccines :
Vaxchora (Used Against Cholera, Live, Oral)
For active immunization against Cholera,Approved by FDA in June 2016PaxVax
Pulmonary/Respiratory Diseases:
a)Bevespi Aerosphere (glycopyrrolate and formoterol fumarate)
b)Cinqair (reslizumab)
c)Tecentriq (atezolizumab)
a)For the treatment of chronic obstructive
pulmonary disease
b)For the treatment of severe asthma,
c)For the treatment of urothelial carcinoma and metastatic non-small cell lung cancer,
a)Approved April 2016
b)Approved March 2016
c)Approved May 2016
a)AstraZeneca
b)Teva Pharmaceuticals
c)Genentech
Neurology:
a)Briviact (brivaracetam)
b)Carnexiv (carbamazepine)
c)Exondys 51 (eteplirsen)
d)Nuplazid (pimavanserin)
e)Onzetra Xsail (sumatriptan nasal powder)
f)Spinraza (nusinersen)
g)Troxyca ER (oxycodone + naltrexone)
h)Zinbryta (daclizumab)
a) For the treatment of partial onset seizures related to epilepsy,
b)replacement therapy when oral administration is not feasible, in adults with seizures,
c)For the treatment of Duchenne muscular dystrophy with mutated DMD gene amenable to exon 51 skipping
d)For the treatment of hallucinations and delusions associated with Parkinson’s disease,
e)For the treatment of migraine
f)For the treatment of spinal muscular atrophy
g)For the management of severe pain
h) For the treatment of relapsing multiple sclerosis
a)Approved February 2016
b)Approved October 2016
c)Approved September 2016
d)Approved April 2016
e)Approved January 2016
f)Approved December 2016
g)Approved August 2016
h)Approved May 2016
a)UCB
b)Lundbeck
c)Sarepta Therapeutics
d)Acadia Pharmaceuticals
e)Avanir;
f)Biogen
g)Pfizer;
h) Biogen
Obstetrics/Gynecology (Women’s Health):
a)Intrarosa (prasterone vaginal inser t)
b)Rubraca (rucaparib)
a)For the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause
b) For the treatment of advanced ovarian cancer in women with deleterious germline or somatic BRCA mutation
a)Approved November 2016
b) Approved December 2016
a)Endoceutics
b)Clovis Oncology
Oncology:
a)Cabometyx (cabozantinib)
b)Keytruda (pembrolizumab)
c)Lartruvo (olaratumab)
d)Lenvima (lenvatinib)
e)Opdivo (nivolumab)
f)Opdivo (nivolumab)
g)Rubraca (rucaparib)
h)Sustol (granisetron)
i)Syndros (dronabinol oral solution)
j)Tecentriq (atezolizumab)
k)Venclexta (venetoclax)
a)For the treatment of advanced renal cell carcinoma
b)For the treatment of head and neck squamous cell cancer
c)For the treatment of soft tissue sarcoma
d)For the treatment of advanced renal cell carcinoma,
e)For the treatment of classical Hodgkin lymphoma
f)For the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck,
g)For the treatment of advanced ovarian cancer in women with deleterious germline or somatic BRCA mutation,
h)For the prevention of chemotherapy-induced nausea and vomiting
i)For the treatment of anorexia associated with AIDS and nausea and vomiting associated with cancer chemotherapy
j) For the treatment of urothelial carcinoma and metastatic non-small cell lung cancer,
k)For the treatment of chronic lymphocytic leukemia with 17p deletion
a)Approved April 2016
b)Approved August 2016
c)Approved October 2016
d)Approved May 2016
e) Approved May 2016
f)Approved November 2016
g)Approved December 2016
h)Approved August 2016
i)Approved July 2016
j)Approved May 2016
k)Approved April 2016
a) Exelixis
b)Merck
c)Eli Lilly
d)Eisai
e)Bristol-Myers Squibb
f)Bristol-Myers Squibb
g)Clovis Oncology
h)Heron Therapeutics
i)Insys Therapeutics
j)Genentech
k) AbbVie
Ophthalmology:
a)Humira (adalimumab)
b)Xiidra (lifitegrast)
a)For the treatment of uveitis,
b)For the treatment of dry eye disease,
a)Approved July 2016
b)Approved July 2016
a)Abbvie
b)Shire
Pediatrics/Neonatology:
a)Exondys 51 (eteplirsen)
b)Kovaltry [Antihemophilic Factor (Recombinant)]
c)Spinraza (nusinersen)
a)For the treatment of Duchenne muscular dystrophy with mutated DMD gene amenable to exon 51 skipping
b)For the treatment of hemophillia A
c)For the treatment of spinal muscular atrophy
a)Approved September 2016
b)Approved March 2016
c)Approved December 2016
a)Sarepta Therapeutics
b)Bayer
c)Biogen;
Pharmacology/Toxicology:
a)Sustol (granisetron)
a)For the prevention of chemotherapy-induced nausea and vomitinga)Approved August 2016a)Heron Therapeutics
Psychiatry/Psychology:
a)Nuplazid (pimavanserin)
a)For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis,a)Approved May 2016a)Acadia Pharmaceuticals
Endocrinology:
a)Adlyxin (lixisenatide)
b)Soliqua 100/33 (insulin glargine and lixisenatide injection)
c)Xultophy 100/3.6 (insulin degludec and liraglutide injection)
a)For the treatment of type II diabetes
b)For the treatment of inadequately controlled type II diabetes
c) For the treatment of inadequately controlled type II diabetes
a)Approved July 2016
b)Approved November 2016
c)Approved November 2016
a)Sanofi Aventis
b)Sanofi Aventis
c)Novo Nordisk
Urology:
Tecentriq (atezolizumab)
For the treatment of urothelial carcinoma and metastatic non-small cell lung cancApproved May 2016Genentech

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