New molecular entities and new biologicals, 2012^a

Aclidinium bromide oral inhalation powder (Tudorza Pressair, Forest), for long-term maintenance therapy in patients with chronic obstructive pulmonary disease

Allogeneic cultured keratinocytes and fibroblasts in bovine collagen, cellular sheet for topical oral application, (Gintuit, Organogenesis), for the treatment of mucogingival conditions in adults

Apixaban oral tablets (Eliquis, Bristol-Myers Squibb), to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation who do not have a prosthetic heart valve

Avanafil oral tablets (Stendra, Vivus), for the treatment of erectile dysfunction

Axitinib oral tablets (Inlyta, Pfizer), as second-line therapy in patients with advanced renal cell carcinoma that has not responded to previously administered systemic agents

Bedaquiline oral tablets (Sirturo, Janssen), as part of combination therapy for the treatment of multidrug-resistant pulmonary tuberculosis when other alternatives are unavailable

Bosutinib oral tablets (Bosulif, Pfizer), as a second-line agent for the treatment of chronic myelogenous leukemia in adults

Cabozantinib oral capsules (Cometriq, Exelixis), for the treatment of progressive, metastatic medullary thyroid cancer

Carfilzomib for i.v. injection (Kyprolis, Onyx), for the treatment of multiple myeloma in patients previously treated with at least two other therapies, including bortezomib and an immunomodulatory agent, whose disease progressed within 60 days after the last treatment

Choline C 11 injection (Mayo Clinic) for use during positron emission tomography to help detect recurrent prostate cancer

Crofelemer delayed-release oral tablets (Fulyzaq, Salix), for the symptomatic relief of noninfectious diarrhea in HIV-infected adults undergoing antiretroviral therapy

Elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate oral tablets (Stribild, Gilead), for the treatment of HIV-1 infection in adults who are new to antiretroviral treatment

Enzalutamide oral capsules (Xtandi, Astellas), for the treatment of advanced prostate cancer

Fibrin sealant patch, absorbable (Evarrest, Ethicon), to stop soft tissue bleeding during open retroperitoneal, intraabdominal, pelvic, and noncardiac thoracic surgery when suture, ligature, or cautery is ineffective or impractical

Florbetapir F 18 injection (Amyvid, Eli Lilly), for imaging amyloid plaques in adults whose cognitive impairment may be due to Alzheimer’s disease or another cause of cognitive decline

Glucarpidase for i.v. injection (Voraxaze, BTG International), for the treatment of toxic plasma methotrexate concentrations in patients whose kidneys are not eliminating the drug at a normal rate

Hematopoietic progenitor cells, cord blood for injection (Ducord, Duke University School of Medicine), for hematopoietic progenitor cell transplantation procedures in patients with inherited, acquired, or myeloablative-treatment-related diseases that affect the hematopoietic system

Hematopoietic progenitor cells, cord blood for injection (Hematopoietic progenitor cells, Clinimmune), for hematopoietic progenitor cell transplantation procedures in patients with inherited, acquired, or myeloablative-treatment-related diseases that affect the hematopoietic system

Icosapent ethyl oral capsules (Vascepa, Amarin), for the reduction of triglyceride levels in adults with hypertriglyceridemia

Immune globulin, human, for i.v. infusion (Bivigam, Biotest), for the treatment of primary humoral immunodeficiency

Influenza virus vaccine, inactivated, for i.m. injection (Fluarix Quadrivalent, Glaxo­SmithKline), for active immunization of children age three years or older and adults against influenza caused by influenza virus subtypes A and type B present in the vaccine

Influenza virus vaccine, inactivated, for i.m. injection (Flucelvax, Novartis), for active immunization of adults against influenza caused by influenza virus subtypes A and type B present in the vaccine

Influenza virus vaccine, live, intranasal spray (FluMist Quadrivalent, MedImmune), for active immunization of people 2–49 years of age against influenza caused by influenza virus subtypes A and type B present in the vaccine

Ingenol mebutate topical gel (Picato, Leo Pharma), for the topical treatment of actinic keratosis

Ivacaftor oral tablets (Kalydeco, Vertex), for the treatment of cystic fibrosis in patients 6 years of age or older whose cystic fibrosis transmembrane conductance regulator gene expresses the G551D mutation

Linaclotide oral capsules (Linzess, Forest), for the treatment of constipation-predominant irritable bowel syndrome and chronic idiopathic constipation in adults

Lomitapide oral capsules (Juxtapid, Aegerion), as part of a regimen for the treatment of patients with homozygous familial hypercholesterolemia

Lorcaserin hydrochloride oral tablets (Belviq, Eisai), for chronic weight management in obese and certain overweight adults, in conjunction with diet and exercise

Lucinactant intratracheal suspension (Surfaxin, Discovery), for the prevention of respiratory distress syndrome in premature infants

Meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine (Menhibrix, GlaxoSmithKline), for immunization against bacterial meningitis in infants and young children

Mirabegron extended-release oral tablets (Myrbetriq, Astellas), for the treatment of overactive bladder in adults

Ocriplasmin intravitreal injection (Jetrea, ThromboGenics), for the treatment of symptomatic vitreomacular adhesion

Omacetaxine mepesuccinate for s.c. injection (Synribo, Teva ), for the second-line treatment of chronic myelogenous leukemia in adults

Pasireotide diaspartate injection (Signifor, Novartis), for the treatment of Cushing’s disease in patients who are not candidates for or did not respond to pituitary surgery

Peginesatide injection (Omontys, Takeda and Affymax), for the treatment of anemia due to chronic kidney disease in adults undergoing dialysis

Perampanel oral tablets (Fycompa, Eisai), as adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy ages 12 years or older

Pertuzumab injection (Perjeta, Genentech), for the treatment of metastatic breast cancer, in combination with trastuzumab and docetaxel

Ponatinib oral tablets (Iclusig, Ariad), as a second-line treatment for all phases of chronic myelogenous leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia in adults

Raxibacumab for i.v. infusion (Abthrax, GlaxoSmithKline), for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis, in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate

Regorafenib oral tablets (Stivarga, Bayer and Onyx), for the treatment of metastatic colorectal cancer in patients previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, antivascular endothelial growth factor therapy, and, for patients with a wild-type Kras gene, antiepidermal growth factor receptor therapy

Sodium picosulfate and magnesium oxide and anhydrous citric acid for oral solution (Prepopik, Ferring), for bowel cleansing before colonoscopy procedures in adults

Tafluprost ophthalmic solution (Zioptan, Merck), for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension

Taliglucerase alfa for i.v. infusion (Elelyso, Pfizer), for the treatment of type 1 Gaucher disease in adults

Tbo-filgrastim for s.c. injection (Neutroval, Teva), for the stimulation of neutrophil production in adults who become neutropenic while undergoing chemotherapy for nonmyeloid cancers

Teduglutide for s.c. injection (Gattex, NPS), for the treatment of short bowel syndrome in adults dependent on parenteral nutrition

Teriflunomide oral tablets (Aubagio, Genzyme), for the treatment of relapsing forms of multiple sclerosis

Tofacitinib oral tablets (Xeljanz, Pfizer), for use as a second-line treatment for moderate-to-severe rheumatoid arthritis in adults

Varicella zoster immune globulin, human, for i.m. injection (Varizig, Cangene), for postexposure prophylaxis to reduce the severity of varicella in people at high risk for complications of the disease

Vismodegib oral capsules (Erivedge, Genentech), for the treatment of adults with locally advanced basal cell cancer who are not candidates for surgery or radiotherapy or whose cancer has metastasized

Ziv-aflibercept for i.v. infusion (Zaltrap, Regeneron and Sanofi), as part of a regimen for the treatment of metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regimen

^a From information available on FDA's website, January 2013. This table does not include medications that have been previously marketed in the United States without an FDA-approved new drug application.