Recent FDA Approvals

What's new in pharmaceutical innovation? Here you can find the latest "New Molecular Entities" (NMEs) and biological products approved by the FDA this year. An NME is a new medicine that has a different molecular structure from any medicines approved before. NMEs and biologics represent just some of the significant pharmaceutical advances approved each year. New medicines this year treat diseases from the very common to the most rare. Some are the first treatment option available for a condition, others improve care for treatable diseases. 

The descriptions here are primarily based on information from the FDA and NIH websites. Additional information about these products, including important safety information, can be obtained from the FDA-approved package insert. 

Natroba – Spinosad (approved 01/18/2011)

For the treatment of head lice

Viibryd – vilazodone hydrochloride (approved 01/21/2011)

For the treatment of major depressive disorder

Corifact – (approved 02/17/2011)

To prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency

Edarbi – azilsartan medoxomil (approved 02/25/2011)

For the treatment of hypertension

Daliresp – roflumilast (approved 02/28/2011)

For the treatment of chronic obstructive pulmonary disease

Benlysta – belimumab (approved 03/10/2011)

For the treatment of systemic lupus erythematosus

Yervoy – ipilimumab (approved 03/25/ 2011)

For the treatment of metastatic melanoma

Horizant – gabapentin enacarbil (approved 04/06/2011)

For the treatment of restless legs syndrome

Vandetanib/Caprelsa – vandetanib (approved 04/06/2011)

For the treatment of thyroid cancer

Zytiga – abiraterone acetate (approved 04/28/2011)

For the treatment of prostate cancer

Tradjenta – linagliptin (approved 05/02/2011)

For the treatment of type II diabetes

Victrelis – boceprevir (approved 05/13/2011)

For the treatment of chronic hepatitis C genotype 1

Edurant – rilpivirine (approved 05/20/2011)

For the treatment of HIV-1

Incivek – telaprevir (approved 05/23/2011)

For the treatment of genotype 1 chronic hepatitis C

Dificid – fidaxomicin (approved 05/27/2011)

For the treatment of Clostridium difficile-associated diarrhea

Potiga – ezogabine (approved 06/10/2011)

For the treatment of partial-onset seizures

Nulojix – belatacept (approved 06/15/2011)

For the prevention of organ rejection following kidney transplant

Arcapta Neohaler – indacaterol maleate inhalation powder (approved 07/01/2011)

For the treatment of airflow obstruction resulting from chronic obstructive pulmonary disease

Xarelto – rivaroxaban (approved 07/01/2011)

For the prophylaxis of deep vein thrombosis during knee or hip replacement surgery

Brilinta – ticagrelor (approved 07/20/2011)

For the reduction of thrombotic events in patients with acute coronary syndrome

Anascorp – (approved 8/3/2011)

For treatment for a scorpion sting

Zelboraf – vemurafenib (approved 08/17/ 2011)

For the treatment of BRAF + melanoma

Adcetris – brentuximab vedotin (approved 08/19/2011)

For the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma

Firazyr – icatibant acetate (approved 08/25/ 2011)

For the treatment of acute attacks of hereditary angioedema

Xalkori – crizotinib (approved 08/26/2011)

For the treatment of ALK+ non-small cell lung cancer

Ferriprox – deferiprone (approved 10/14/2011)

For the treatment of transfusional iron overload due to thalassemia

Onfi – clobazam (approved 10/21/2011)

For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome

Jakafi – ruxolitinib (approved 11/16/2011)

For the treatment of myelofibrosis