Number of New Medicinal Products

The number of new medicinal products is calculated from the information available on the EMA and FDA websites.

MA USAMA EUActive substanceCondition
2010 collagenase clostridium histolyticum Dupuytren's contracture with a palpable cord
2010dalfampridineMultiple sclerosis
2010dexamethasone intravitreal implantNon-infectious uveitis affecting the posterior segment of the eye
20102011everolimus Subependymal giant cell astrocytoma associated with tuberous sclerosis
2010glycopyrrolateNeurologic conditions associated with problem drooling
20142010ofatumumabChronic lymphocytic leukaemia
2010pegloticaseChronic gout
2010repository corticotropin or adrenocorticotropic hormone Infantile spasms
2010rifaximinOvert hepatic encephalopathy recurrence
2010rituximabCD20-positive chronic lymphocytic leukemia
2010tenofovirHIV infection
2010thiotepaHaematological diseases or solid tumours
2010trastuzumabHER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma
20102010velaglucerase-alfa Type I Gaucher Disease
2011 belatacept Organ rejection in kidney transplants
2011 2012brentuximab vedotin Systemic anaplastic large cell lymphoma
2011 2012brentuximab vedotin Hodgkin lymphoma
2011 centruroides immune F(ab)2 Scorpion envenomation
2011 cinacalcet Severe hypercalcemia in patients with primary hyperparathyroidism
2011 clobazam Seizures associated with Lennox-Gastaut Syndrome
2011 coccidioidin SD Skin Test Antigen Delayed type hypersensitivity to C. immitis
2011crizotinibLocally advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase-positive
2011deferiproneTransfusional iron overload due to thalassemia syndromes
2011eculizumabAtypical hemolytic uremic syndrome
2011erwinia L-asparaginase Acute lymphoblastic leukemia with hypersensitivity to E. coli-derived asparaginase
2011everolimusProgressive neuroendocrine tumors of pancreatic origin in metastatic disease
2011factor XIII concentrate (human)Congenital factor XIII deficiency
2011gabapentin Post-herpetic neuralgia
2011hydrocortisoneAdrenal insufficiency
2011hydroxyprogesterone caproatePreterm birth in women with singleton pregnancy
2011infliximabModerately to severely active ulcerative colitis
2011ipilimumabUnresectable or metastatic melanoma
2011levoleucovorinAdvanced metastatic colorectal cancer
2011peginterferon alfa-2b Melanoma with microscopic or gross nodal involvement
20142011pirfenidoneMild to moderate idiopathic pulmonary fibrosis
2011rituximab Wegener's Granulomatosis and Microscopic Polyangiitis
2011romidepsin Treatment of non-Hodgkin T-cell lymphomas
20112012ruxolitinib phosphateIntermediate or high-risk myelofibrosis
2011sodium nitrite and sodium thiosulfateCyanide poisoning
2011tafamidisTransthyretin amyloidosis in stage-1 symptomatic polyneuropathy
2011tobramycin Chronic pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis
2011vandetanibAsymptomatic or progressive medullary thyroid cancer in unresectable locally advanced or metastatic disease
2011vemurafenibUnresectable or metastatic melanoma with BRAF V600E mutation
2012 6-mercaptopurine monohydrateAcute lymphoblastic leukemia
2012 alipogene tiparvovec Familial lipoprotein lipase deficiency and severe or multiple pancreatitis attacks
2012 anakinra Neonatal-onset multisystem inflammatory disease
2012 2014bedaquiline; (1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol Pulmonary multi-drug resistant tuberculosis
2012 2013bosutinib Philadelphia chromosome-positive chronic myelogenous leukemia
2012 2014cabozantinib Progressive metastatic medullary thyroid cancer
2012 2015carfilzomib Multiple myeloma
2012concentrate of proteolytic enzymes enriched in bromelainFor removal of eschar in deep partial- and full-thickness thermal burns
2012cysteamine hydrochloride Corneal cystine crystal accumulation in cystinosis
2012difluprednateEndogenous anterior uveitis
2012everolimus Renal angiomyolipoma and tuberous sclerosis complex
2012gabapentin enacarbil Post-herpetic neuralgia in adults
2012glucarpidaseToxic plasma methotrexate concentrations in delayed methotrexate clearance due to impaired renal function
2012immune globulin infusion (human) Multifocal motor neuropathy
20122012ivacaftorCystic fibrosis with a G551D mutation in the CFTR gene
2012lomitapide Homozygous familial hypercholesterolemia
2012mannitol Cystic fibrosis
2012mifepristoneHyperglycemia in Cushing's syndrome
2012mitomycin-C Glaucoma
2012omacetaxine mepesuccinate Chronic or accelerated phase chronic myeloid leukemia
20122012pasireotide Cushing's disease
2012pazopanibAdvanced soft tissue sarcoma
2012ponatinib Chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia
2012raxibacumabInhalation anthrax due to Bacillus anthracis
2012taliglucerase alfa Type 1 Gaucher disease
2012technetium Tc99m sulfur colloid injection, lyophilized Lymph nodes draining a primary tumor in melanoma
20122012teduglutide [rDNA origin]Short bowel syndrome
2012varicella Zoster Immune Globulin (Human) Varicella
2012vinCRIStine sulfate LIPOSOME injectionPhiladelphia chromosome-negative acute lymphoblastic leukemia
2013 afatinib Metastatic non-small cell lung cancer
2013anti-inhibitor coagulant complexHemophilia A and B
2013 botulism antitoxin heptavalent (A, B, C, D, E, F, G) (Equine) Symptomatic botulism
20152013 cholic acid Inborn errors in primary bile-acid synthesis due to 3-hydroxy-5-C27-steroid oxidoreductase deficiency
2013cholic acidInborn errors in primary bile-acid synthesis due to 4-3-oxosteroid-5-reductase deficiency
2013 coagulation factor IX (recombinant) Hemophilia B
2013collagenase clostridium histolyticumPeyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees
2013cysteamine enteric coatedNephropathic cystinosis
2013dabrafenib Unresectable or metastatic melanoma with BRAF V600E mutation
20162013 defibrotide Severe hepatic veno-occlusive disease also known as sinusoidal obstructive syndrome
2013 denosumab Giant cell tumor of bone
2013 enalapril maleate (powder for oral solution) Hypertension
2013 Factor XIII A-Subunit (recombinant) Congenital factor XIII A-subunit deficiency
2013 factor XIII concentrate (human) Congenital factor XIII deficiency
2013 2015glycerol phenylbutyrate Urea cycle disorders
2013 2014ibrutinib Mantle cell lymphoma
2013imatinib Treatment of Philadelphia-positive acute lymphoblastic leukemia
2013 immune globulin intraveous (human) Idiopathic thrombocytopenic purpura
2013 2013macitentan Pulmonary arterial hypertension
2013 meclorethamine Stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma
2013mercaptamine Treatment of proven nephropathic cystinosi
2013 mipomersen Homozygous familial hypercholesterolemia
2013 nimodipine Ischemic deficits in subarachnoid hemorrhage from ruptured intracranial berry aneurysms
20132014obinutuzumabChronic lymphocytic leukemia
2013 paclitaxel protein-bound particles Metastatic adenocarcinoma of the pancreas
2013 2013 pomalidomide Multiple myeloma
2013 prothrombin complex concentrate (human) Acquired coagulation factor deficiency induced by Vitamin K antagonist
2013 regorafenib Locally advanced, unresectable or metastatic gastrointestinal stromal tumor
2013 2014riociguat Persistent/recurrent chronic thromboembolic pulmonary hypertension
2013 riociguat Pulmonary arterial hypertension
2013tocilizumabActive polyarticular juvenile idiopathic arthritis
2013trametinibUnresectable or metastatic melanoma with BRAF V600E or V600K mutations
2014adalimumabPediatric Crohn's disease and severe hidradenitis suppurativa
2014afamelanotideErythropoietic protoporphyria
2014antihemophilic factor (recombinant), Fc fusion proteinHemophilia A (congenital factor VIII deficiency)
20142015antihemophilic factor (recombinant), porcine sequenceAcquired hemophilia A
2014aripiprazoleTourette's syndrome
2014atalurenDuchenne muscular dystrophy
2014beleodaqPeripheral T-cell lymphoma
2014blinatumomabAcute lymphocytic leukemia
2014C1-esterase inhibitor (recombinant)Hereditary angioedema
2014ceritinibAnaplastic lymphoma kinase positive metastatic non-small cell lung cancer
20152014cholic acidInborn errors in primary bile acid synthesis due to sterol 27-hydroxylase deficiency
20152014cholic acidInborn errors in primary bile acid synthesis due to 2- (or alpha-) methylacyl-CoA racemase (AMACR) deficiency
20152014cholic acidInborn errors in primary bile acid synthesis due to cholesterol 7alpha-hydroxylase (CYP7A1) deficiency
2014coagulation factor VIIa (recombinant)Glanzmann's thrombasthenia with refractoriness to platelet transfusions
2014Coagulation factor IX (recombinant), Fc fusion protein Control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease)
2014dantrolene sodium suspension for injectionMalignant hyperthermia
2014delamanid Pulmonary multi-drug resistant tuberculosis
2014droxidopaOrthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy
2014ecallantide Treatment of angioedema
20142015eliglustatGaucher disease type 1
2014elosulfase alfaMucopolysaccharidosis type IVA
2014eltrombopagAplastic anemia
2014ethiodized oil injection Tumors in hepatocellular carcinoma
20142014ibrutinibChronic lymphocytic leukemia
2014idelalisibChronic lymphocytic leukemia and small lymphocytic lymphoma
2014idelalisibFollicular lymphoma
2014ketoconazoleCushing syndrome
2014lanreotide acetateTreatment of neuroendocrine tumors
2014mercaptopurine oral solution Acute lymphoblastic leukemia
2014metreleptinLeptin deficiency in congenital or acquired generalized lipodystrophy
2014miltefosineVisceral leishmaniasis due to Leishmania donovani; cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis; mucosal leishmaniasis due to Leishmania braziliensis 
20142015nintedanibIdiopathic pulmonary fibrosis
20142014olaparibTreatment of ovarian cancer
2014para-aminosalicylic acid Treatment of multi-drug resistant tuberculosis
2014pasireotideTreatment of acromegaly
2014pembrolizumabStage IIB through IV malignant melanoma, unresectable or metastatic melanoma
2014propranolol Treatment of proliferating infantile hemangiomas requiring systemic therapy
2014ramucirumabAdvanced gastric cancer or gastro-esophageal junction adenocarcinoma
2014Recombinant human acid alpha-glucosidase; alglucosidase alfa Patients with Pompe disease (acid alpha-glucosidase (GAA deficiency)
2014 ruxolitinib phosphate Treatment of patients with polycythemia vera, a chronic type of bone marrow disease, and who have had an inadequate response to or are intolerant to hydroxyurea. Jakafi is the first drug approved by the FDA for this condition.
20142014siltuximabMulticentric Castleman's disease
20142015tasimelteonNon-24-hour sleep-wake disorder
2014trametinib and dabrafenibUnresectable or metastatic melanoma with BRAF V600E or V600K mutations
2015adalimumab Treatment of moderate to severe hidradenitis suppurativa
2015alectinib Treatment of ALK-positive non-small cell lung cancer
2015anthrax immune globulin (human) Treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs
2015Antivenin crotaline (pit-viper) equine immune F(ab)2)Treatment of envenomation by Crotaline snakes
20152015Asfotase alfa Treatment of hypophosphatasia
2015cobimetinibTreatment of stage IIb, IIc, III, and IV melanoma with BRAFV600 mutation
2015Combination of nivolumab and ipilimumabTreatment of Stage IIb to Stage IV melanoma
2015daratumumab Treatment of multiple myeloma
2015dichlorphenamideTreatment of primary hyperkalemic periodic paralysis, primary hypokalemic period paralysis, and related variants
20152015dinutuximabTreatment of neuroblastoma, a nerve cell cancer, in children aged 12 months to 17 years.
2015efmoroctocog alfaTreatment of Haemophilia A.
2015evolocumab As an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with HoFH who require additional lowering of LDL-C.
2015ex vivo expanded autologous human corneal epithelial cells containing stem cellsStem-cell treatment used in the eye to replace damaged cells on surface (epithelium) of the cornea, the transparent layer in front of the eye covering the iris (the coloured part).
2015Human factor X Treatment of hereditary factor X deficiency
2015ibrutinibTreatment of patients with Waldenstrom's macroglobulinemia
2015idarucizumab To reverse the anticoagulant effect of dabigatran due to uncontrolled life-threatening bleeding requiring urgent intervention or a need to undergo an emergency surgery/urgent invasive procedure
2015idebenone Treatment of visual impairment in adults and adolescents aged 12 years and over with Leber’s hereditary optic neuropathy (LHON),
2015isavuconazole Treatment of Aspergillosis
20152015isavuconazonium sulfate Treatment of invasive aspergillosis in patienst 18 years of age and older
2015ixazomib citrate Treatment of multiple myeloma
2015lenvatinib Treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine refractory differentiated thyroid cancer
2015Levodopa and carbidopa Treatment of motor flucuations in patients with advanced Parkinson's disease
2015liposomal irinotecan Treatment of pancreatic cancer
2015lumacaftor/ivacaftor Treatment of cystic fibrosis in patients age 12 years and older who are homozygous for F508del mutation in the CFTR gene
2015N-(2-{2-dimethylaminoethyl-methylamino}-4-methoxy-5-{[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide mesylate salt Treatment of epidermal growth factor receptor mutation-positive non-small cell lung cancer
2015necitumumab Treatment of squamous non-small cell lung cancer
20152015panobinostat Farydak is a cancer medicine used in combination with two other medicines, bortezomib and dexamethasone, to treat multiple myeloma (a cancer of the bone marrow).
2015 parathyroid hormone Treatment of hypoparathyroidism. An adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism
2015Pegfilgrastim Treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident
2015phoxilium As a replacement solution in Continuous Renal Replacement Therapy (CRRT) and in case of drug poisoning when CRRT is used to remove dialzable substances
20152015sebelipase alfa Treatment of lysosomal acid lipase deficiency
2015selexipag Treatment of pulmonary arterial hypertension
2015uridine triacetate Treatment of hereditary orotic aciduria
2015uridine triacetate Treatment of 5-fluorouracil poisoning
2016acetylcysteine effervescent tablets for oral solution Preventing hepatic injury from acetaminophin overdose
2016 afatinibTreatment of non-small cell lung cancer with squamous histology.
2016 eribulin mesylateTreatment of advanced soft tissue sarcoma
2016 human coagulation factor X Treatment of Factor X Deficiency
2016 melphalan High dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation
2016 methylene blue0.5% Treatment of hereditary and acquired methemoglobinemia
2016 obiltoxaximab Treatment of exposure to B. anthracis spores
2016 obinutuzumab Treatment of follicular lymphoma
2016 pitolisant Treatment of Narcolepsy
2016 recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) Treatment of patients with congenital factor IX deficiency (hemophilia B).
2016 riboflavin ophthalmic solution & ultraviolet A Treatment of keratoconus
2016 venetoclax Treatment of acute myeloid leukemia.

This page was updated on April 26, 2016.