Drug Approvals

	A	B	C	D	E	F	G	H	K
1	Company	Proprietary Name	Established Name	Indication	Region of Approval	Date Approved	First Published	Compound Type

2	Novo Nordisk	Saxenda	liraglutide	Chronic weight management as an adjunct to diet and exercise in obese adults or in overweight adults with at least one co-morbidity	United States	12/23/2014			PDUFA date was 10/20/2014
3	Bristol-Myers Squibb	Opdivo	nivolumab	Previously treated advanced melanoma	United States	12/22/2014		Priority review	Accelerated approval (PDUFA was 3/30/15)
4	AstraZeneca	Lynparza	olaparib	Monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer detected by an FDA-approved test	United States	12/19/2014			Accelerated approval
5	Cubist Pharmaceuticals	Zerbaxa	ceftolozane/tazobactam combo	Adults with complicated intra-abdominal infections and complicated urinary tract infections	United States	12/19/2014			Priority Review
6	AbbVie	Viekira Pak	ombitasvir, paritaprevir, Norvir ritonavir combo and dasabuvir	with or without ribavirin to treat HCV genotype 1 infection in patients with and without compensated cirrhosis.	United States	12/19/2014
7	Amgen	Blincyto	blinatumomab	Philadelphia chromosome-negative precursor B cell acute lymphoblastic leukemia	United States	12/3/2014		BLA	Priority review - approved 5 months ahead of PDUFA date
8	Pfizer	Trumenba	meningococcal disease	Prevention of meningitis B vaccine	United States	10/29/2014			Breakthrough therapy; priority review
9	Boehringer Ingelheim	Ofev	nintedanib	Idiopathic pulmonary fibrosis	United States	10/15/2014		Small molecule	Accelerated approval - breakthrough and fast track
10	Genentech (Roche) and Intermune	Esbriet	pirfenidone	Idiopathic pulmonary fibrosis	United States	10/15/2014		Small molecule	Accelerated approval - breakthrough and fast track
11	Gilead Sciences	Harvoni	ledipasvir/sofosbuvir combo	Genotype 1 hepatitis C	United States	10/10/2014		Small molecule
12	Helsinn Healthcare; Eisai	Akynzeo	Netupitant; palonosetron hydrochloride	Prevention of chomtherapy side effects of nausea and vomiting	United States	10/10/2014		Small molecule
13	Eli Lilly	Trulicity	dalaglutide	improve glycemic control in Type II diabetes patients, in conjunction with diet and exercise.	United States	9/18/2014		BLA	boxed warning of increased risk for thyroid C-cell tumors based on preclinical studies. FDA approved Trulicity with a REMS.
14	Nektar Therapeutics and AstraZeneca	Movantik	naloxegol	Opioid-induced constipation in adult patients with chronic non-cancer pain	United States	9/16/2014
15	Orexigen	Contrave	Bupropion and naltrexone	Weight loss	United States	9/10/2014
16	Keryx Biopharmaceuticals	Zerenex	ferric citrate	Hyperphosphatemia in CKD patients	United States	9/5/2015		Small molecule
17	Merck	Keytruda	pembrolizumab	Advanced melanoma in patients previously treated with Yervoy	United States	9/3/2014		Biologic	First PD-1 inhibitor approved in the US; accelerated approval [programmed cell death immunotherapy]
18	Genzyme (Sanofi)	Cerdelga	eliglustat	Type 1 Gaucher's disease	United States	8/19/2014
19	Merck	Belsomra	suvorexant	Insomnia	United States	8/13/2014
20	Janssen Pharma (J&J)	Invokamet	canagliflozin and metformin hydrochloride	Improvement of glycemic control in type 2 diabetics	United States	8/8/2014
21	The Medicines Company	Orbactiv	IV oritavancin	Acute bacterial skin and skin structure infections caused by Gram-positive bacteria	United States	8/6/2014			Priority review; Qualified Infectious Disease Product
22	Boehringer Ingelheim and Eli Lilly	Jardiance	empagliflozin	Type 2 diabetes	United States	8/1/2014			Rejected on first try 3/25/14
23	Boehringer Ingelheim	Striverdi Respimat	Olodaterol respimat	Once-daily long-acting beta2 agonist inhaler to treat COPD	United States	7/31/2014
24	Gilead Sciences	Zydelig	idelalisib	Three blood cancers: in combo with rituximab in CLL; relapsed vollicular B cell non-Hodgkin's lymphoma; relapsed small lymphocytic lymphoma	United States	7/23/2014		Small molecule	Had breakthrough therapy designation for combo treatment; original PDUFA date 9/11
25	Salix Pharmaceuticals; Pharming	Ruconest	conestat alfa	acute angioedema attacks in adult and adolescent patients with hereditary angioedema	United States	7/17/2014
26	Anacor Pharmaceuticals	Kerydin	tavaborole	Onychomycosis o fthe toenails [antifungal]	United States	7/8/2014
27	Spectrum Pharmaceuticals	Beleodaq	belinostat	Relapsed or refractory peripheral T-cell lymphoma (PTCL)	United States	7/2/2014		Small molecule HDAC inhibitor	approved one month ahead of schedule under accelerated approval, post-market study required
28	MannKind	Afrezza	Inhaled insulin	Improvement of glycemic control in type 1 and type 2 diabetics	United States	6/27/2014			Approved on third submission
29	Cubist Pharmaceuticals	Sivextro	second generation oxazolidinone	Acute bacterial skin and skin structure infections caused by susceptible bacteria, including MRSA	United States	6/20/2014		Small molecule
30	Biogen Idec	Eloctate	recombinant factor VIII Fc fusion protein	Hemophilia A	United States	6/6/2014
31	Valeant Pharmaceuticals	Jublia	efinaconazole	First topical treatment for onychomycosis of the toenails	United States	6/6/2014
32	Durata Therapeutics	Dalvance	dalvavancin	Acute bacterial skin and skin structure infections caused by Gram-positive bacteria	United States	5/23/2014		Small molecule	Priority review; QIDP designation giving it additional five years of marketing exclusivity
33	Millenium (Takeda Pharmaceuticals)	Entyvio	vedolizumab	Moderate to severe ulcerative colitis and moderate to severe Crohn's disease in adults who have not responded to one or more standard therapies	United States	5/20/2014		Biologic	Priority review
34	Merck	Zontivity	Vorapaxar	Reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.	United States	5/8/2014		Small molecule
35	Novartis	Zykadia	Ceritinib	ALK-positive metastatic non-small cell lung cancer in patients who have progressed on or who are intolerant to Pfizer's Xalkori	United States	4/29/2014		Small molecule
36	Janssen Biotech	Sylvant	Siltuximab	Multicentric Castleman's disease (rare blood disorder) in patients who are HIV-negative and human herpes virus 8-negative	United States	4/22/2014		Biologic	BLA
37	Eli Lilly	Cyramza	Ramucirumab	Monotherapy for advanced stomach cancer or gastroesophageal junction adenocarcinoma after prior fluoropyrimidine- or platinum-containing chemotherapy	United States	4/21/2014		Biologic	BLA
38	GlaxoSmithKline	Tanzeum	Albiglutide	Type 2 diabetes as monotherapy or as add-on therapy	United States	4/15/2014		Biologic	BLA
39	Biogen Idec	Alprolix	recombinant factor IX Fc fusion protein	Hemophilia B	United States	3/28/2014		Biologic
40	Celgene	Otezla	apremilast	Adults with active psoriatic arthritis	United States	3/21/2014		Small molecule
41	Knight Therapeutics	Impavido	miltefosine	Cutaneous or mucosal leishmaniasis	United States	3/19/2014		Small molecule	Tropical Disease Priority Review, voucher granted for another program
42	AstraZeneca (Amylin)	Myalept	metreleptin	Lypodystrophy	United States	2/24/2014
43	Chelsea Therapeutics	Northera	droxidopa	Neurogenic orthostatic hypotension (Rare disorder--extremely low blood pressure)	United States	2/18/2014		Small molecule	Accelerated Approval
44	BioMarin Pharmaceuticals	Vimizim	elosulfase alfa	Mucopolysaccharidosis [Morquio's syndrome]	United States	2/14/2014		Biologic
45	Pharmacyclics and Johnson & Johnson	Imbruvica	ibrutinib	Chronic lymphocytic leukemia	United States	2/12/2014		Biologic	Priority review, Breakthrough Therapy
46	Vanda Pharmaceuticals	Hetlioz	Tasimelteon	Non-24-hour sleep-wake disorder in totally blind individuals	United States	1/31/2014
47	AstraZeneca	Farxiga	dapagliflozin	Glycemic control in type 2 diabetes	United States	1/7/2014		Small molecule
48
49	GlaxoSmithKline Theravance	Anoro Ellipta	umeclidinium bromide and vilanterol	Chronic obstructive pulmonary disease	United States	12/18/2013		Small Molecule
50	Gilead Sciences	Sovaldi	sofosbuvir	Chronic hepatitis C virus infection	United States	12/6/2013		Small Molecule
51	Janssen (J&J) and Medivir	Olysio	simeprevir	Chronic hepatitis C virus infection	United States	11/23/2013		Small Molecule
52	Janssen	Invokana	canagliflozin	Type 2 diabetes	Europe	11/23/2013		Small Molecule
53	Roche and ImmunoGen	Kadcyla	T-DM1 / trastuzumab emtansine	HER2-positive, metastatic breast cancer in patients who previously received trastuzumab and a taxane	Europe	11/20/2013		Biologic
54	GlaxoSmithKline Theravance	Relvar Ellipta	fluticasone furoate and vilanterol inhalation powder	Asthma and chronic obstructive pulmonary disease in adults with a history of exacerbations	Europe	11/18/2013		Small Molecule
55	Bayer	Xofigo	radium Ra 223 dichloride	Metastatic castration-resistant prostate cancer	Europe	11/15/2013		Small Molecule
56	Medicis (Valeant Pharmaceuticals	Luzu	luliconazole	Topical antifungal for athlete's foot	United States	11/14/2013
57	Pharmacyclics and Johnson & Johnson	Imbruvica	ibrutinib	Relapsed or refractory mantle cell lymphoma in patientsh who have received at least one prior therapy	United States	11/13/2013	11/13/2013	Biologic
58	Sunovion Pharmaceuticals (Dainippon Sumitomo Pharma)	Aptiom	eslicarbazepine acetate	Adjunctive treatment for partial-onset epileptic siezures in adults	United States	11/8/2013	11/8/2013	Small Molecule
59	Genentech (Roche)	Gazyva	obinutuzumab	Chronic Lymphocytic Leukemia	United States	11/1/2013	11/1/2013	Biologic
60	GE Healthcare	Vizamyl	flutemetamol F 18	Radioactive diagnostic drug for use with PET imaging of the brain in adults being evaluated for Alzheimer's disease and dementia	United States	10/25/2013	10/25/2013	Small Molecule	20
61	Actelion Pharmaceuticals	Opsumit	macitentan	Pulmonary arterial hypertension	United States	10/18/2013	10/18/2013	Small Molecule
62	Bayer	Adempas	riociguat	Pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension	United States	9/8/2013	9/8/2013	Small Molecule
63	Lundbeck Otsuka Pharmaceutical	Brintellix	vortioxetine	Major depressive disorder	United States	9/30/2013	9/30/2013	Small Molecule
64	Boehringer Ingelheim	Giotrif	afatinib	Metastatic non-small cell lung cancer w/ epidermal growth factor receptor exon 19 deletions or exon 21 substitution mutations	Europe	9/25/2013	10/16/2013	Small Molecule
65	Takeda	Incresync	alogliptin / pioglitazone	Type 2 diabetes	Europe	9/19/2013	10/14/2013	Small Molecule
66	Takeda	Vipdomet	alogliptin / metformin	Type 2 diabetes	Europe	9/19/2013	10/14/2013	Small Molecule
67	Takeda	Vipidia	alogliptin	Type 2 diabetes	Europe	9/19/2013	10/15/2013	Small Molecule
68	Novartis	Xoterna Breezhaler	indacaterol / glycopyrronium bromide	Chronic obstructive pulmonary disease	Europe	9/19/2013	10/4/2013	Small Molecule
69	Hospira	Inflectra	infliximab	Spondylitis, AnkylosingArthritis, RheumatoidArthritis, PsoriaticCrohn DiseasePsoriasis	Europe	9/10/2013	10/4/2013	Biologic (Biosimilar)
70	Celltrion	Remsima	infliximab	Spondylitis, AnkylosingArthritis, RheumatoidArthritis, PsoriaticCrohn DiseasePsoriasis	Europe	9/10/2013	10/4/2013	Biologic (Biosimilar)
71	Novartis	Votubia	everolimus	Tuberous sclerosis	Europe	9/2/2013	9/19/2013	Small Molecule
72	Abbott Laboratories	Cholib	fenofibrate / simvastatin	Dyslipidemia	Europe	8/26/2013	9/18/2013
73	GlaxoSmithKline	Tafinlar	dabrafenib	BRAF V600 mutation-positive metastatic melanoma	Europe	8/26/2013	9/18/2013
74	Bayer	Strivarga	regorafenib	Metastatic colorectal cancer	Europe	8/26/2013	9/12/2013
75	Celgene	Pomalidomide Celgene	pomalidomide	Multiple myeloma	Europe	8/5/2013	8/13/2013	Small Molecule
76	ViiV Healthcare	Tivicay	dolutegravir	HIV-1	United States	8/12/2013	8/12/2013	Small Molecule
77	Aegerion Pharmaceuticals	Lojuxta	lomitapide	homozygous familial hypercholesterolemia	Europe	8/1/2013		Small Molecule
78	Roche	Erivedge	vismodegib	Basal cell carcinoma	Europe	7/12/2013	7/30/2013	Biologic
79	Boehringer Ingelheim	Gilotrif	afatnib	Metastatic non-small cell lung cancer w/ epidermal growth factor receptor exon 19 deletions or exon 21 substitution mutations	United States	7/12/2013	7/12/2013	Small Molecule
80	Ariad Pharmaceuticals	Iclusig	ponatinib	Chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia	Europe	7/1/2013	7/11/2013	Biologic
81	Genzyme	Maci	autologous cultured chondrocytes	Implant used to repair cartilage defects at the ends of the bones of the knee joint	Europe	6/27/2013	7/12/2013
82	Jenson Pharmaceutical	Nuedexta	dextromethorphan / quinidine	Pseudobulbar affect	Europe	6/24/2013	7/2/2013	Small Molecule
83	Vivus	Spedra	avanafil	Erectile dysfunction	Europe	6/21/2013	7/3/2013	Small Molecule
84	Astellas Pharma	Xtandi	enzalutamide	Prostate cancer	Europe	6/21/2013	7/2/2013	Small Molecule
85	GlaxoSmithKline	Mekinist	trametinib	Metastatic melanoma	United States	5/29/2013	5/29/2013	Small Molecule
86	GlaxoSmithKline	Tafinlar	dabrafenib	Metastatic melanoma	United States	5/29/2013	5/29/2013	Small Molecule
87	Gilead Sciences	Stribild	elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil	HIV-1	Europe	5/24/2013	6/13/2013	Small Molecule
88	Baxter	HyQvia	human normal immunoglobulin	Immunodeficiency syndromes	Europe	5/16/2013	6/3/2013	Biologic
89	Bayer Pharmaceuticals	Xofigo	radium Ra 223 dichloride	Metastatic castration-resistant prostate cancer	United States	5/15/2013	5/15/2013	Small Molecule
90	GlaxoSmithKline Theravance	Breo Ellipta	fluticasone furoate and vilanterol inhalation powder	Chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema	United States	5/10/2013	5/10/2013	Small Molecule
91	Sanofi Pasteur MSD	Hexyon	diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)	Vaccine against meningitis, haemophilus, hepatitis B, diphtheria, poliomyelitis, whooping cough, tetanus	Europe	4/17/2013	7/12/2013
92	Sanofi Pasteur	Hexacima	diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)	Vaccine against diphtheria,tetanus, pertussis, hepatitis B, poliomyelitis, and invasive diseases (such as meningitis) caused by H. influenzae type b bacteria.	Europe	4/17/2013	7/12/2013
93	Janssen	Invokana	canagliflozin	Type 2 diabetes	United States	3/29/2013	3/29/2013
94	Biogen Idec	Tecfidera	dimethyl fumarate	Relapsing forms of multiple sclerosis	United States	3/27/2013	3/27/2013
95	Pfizer	Bosulif	bosutinib	Chronic myeloid leukaemia	Europe	3/27/2013	4/9/2013	Biologic
96	Guerbet	Dotarem	gadoterate meglumine	Contrast agent for use in MRI of the brain, spine and associated tissues	United States	3/20/2013	3/20/2013
97	Navidea Biopharmaceuticals	Lymphoseek	technetium Tc 99m tilmanocept	Diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma	United States	3/13/2013	3/13/2013	Small Molecule
98	ThromboGenics	Jetrea	ocriplasmin	Vitreomacular traction	Europe	3/13/2013	4/18/2013	Biologic
99	Roche	Perjeta	pertuzumab	First-line HER2-positive metastatic or locally recurrent unresectable breast cancer	Europe	3/4/2013	4/2/2013
100	QuatRx Pharmaceuticals Shionogi	Osphena	ospemifene	Vulvar and vaginal atrophy due to menopause	United States	2/26/2013	2/26/2013	Small Molecule