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New Molecular Entity Approvals for 2011


The availability of new drugs often means new treatment options for patients, and advances in health care for the American public. For this reason, "innovation" is a key word throughout the pharmaceutical industry and the healthcare community. FDA's Center for Drug Evaluation and Research (CDER) regulates over-the-counter and brand name and generic prescription drugs. In this function, CDER supports innovation and plays a key role in helping to advance new drug development.
 

In calendar year 2011, CDER approved a wide range of new brand name and generic drug products. Many are duplicate therapies that will compete in the marketplace with the same kind of products already approved. But some are new and innovative chemical structures never used before in clinical practice. Such novel new drugs are often called new molecular entities (NMEs). Many of these products offer new hope for patients suffering from the conditions these products are intended to treat. The list below includes the NMEs approved by CDER in calendar year 2011.
 

FDA's Center for Biologics Evaluation and Research (CBER) approves biological drugs. At the end of Fiscal Year 2011, FDA examined the combined drug approvals of both CDER and CBER for FY 2011 (see report).
 

Below summarizes the NMEs approved by CDER in calendar year 2011:


(The Drug Name link will provide you with full product details, i.e., prescribing information, approval history, and reviews)

 Persons with disabilities having problems accessing these PDFs may call (301) 796-3634 for assistance.

 2011 Novel New Drugs

2011 Novel New Drugs


 CDER User Fee Performance and New Drug Approvals 2011

CDER User Fee Performance &
Drug Approvals - 2011

Drug Name

Active Ingredient

Date

What it’s used for

Eylea

aflibercept

11/18

To treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older.
Press Release

Erwinaze

asparaginase Erwinia chrysanthemi

11/18

To treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs used to treat ALL.
Press Release

Jakafi

ruxolitinib

11/16

To treat patients with the bone marrow disease myelofibrosis.
Press Release

Onfi

clobazam

10/24

For use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older.
Press Release

Ferriprox

deferiprone

10/14

To treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy.
Press Release

Xalkori

crizotinib

08/26

To treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.
Press Release 

Firazyr

icatibant

08/25

For the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older.
Press Release 

Adcetris

brentuximab vedotin

08/19

For the treatment of Hodgkin lymphoma and ALCL (systemic anaplastic large cell lymphoma). Press Release

Zelboraf

vemurafenib

08/17

To treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.
Press Release 

Brilinta

ticagrelor

07/20

To reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).
Press Release 

Xarelto

rivaroxaban

07/01

To reduce the risk of blood clots, deep vein thrombosis (DVT), and pulmonary embolism (PE) following knee or hip replacement surgery.
Press Release 

Arcapta Neohaler

indacaterol inhalation powder

07/01

For the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.
Press Release 

Nulojix

belatacept

06/15

To prevent acute rejection in adult patients who have had a kidney transplant.
Press Release 

Potiga

ezogabine

06/10

For use as an add-on medication to treat seizures associated with epilepsy in adults.
Press Release 

Dificid

fidaxomicin

05/27

For the treatment of Clostridium difficile-associated diarrhea (CDAD).
Press Release 

Incivek

telaprevir

05/23

To treat certain adults with chronic hepatitis C infection.
FDA Briefing on New Hepatitis C Drugs
Consumer Information on Hepatitis B and C

Edurant

rilpivirine

05/20

For the treatment of HIV-1 infection in adults who have never taken HIV therapy.
Press Release 

Victrelis

boceprevir

05/13

To treat certain adults with chronic hepatitis C.
Press Release 
FDA Briefing on New Hepatitis C Drugs
Consumer Information on Hepatitis B and C

Tradjenta

linagliptin

05/02

An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Press Release 

Zytiga

abiraterone acetate

04/28

In combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).
Press Release 

Caprelsa

vandetanib

04/06

To treat adult patients with late-stage (metastatic) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms.
Press Release 

Horizant

gabapentin enacarbil

04/06

A once-daily treatment for moderate-to-severe restless legs syndrome (RLS).
Press Release 

Yervoy

ipilimumab

03/25

To treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.
Press Release 

Gadavist

gadobutrol

03/14

For use in patients undergoing magnetic resonance imaging (MRI) of the central nervous system. 
Press Release 

Benlysta

belimumab

03/9

To treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs.
Press Release 

Daliresp

roflumilast

02/28

To decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).
Press Release

Edarbi

azilsartan medoxomil

02/25

To treat high blood pressure (hypertension) in adults.
Press Release 

Viibryd

vilazodone hydrochloride

01/21

To treat major depressive disorder in adults.
Press Release

Natroba

spinosad

01/18

For the treatment of head lice infestation in patients ages 4 years and older. 
Press Release

Datscan

ioflupane i-123

01/14 

An imaging drug used to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS).