"Spotlight on Drug Innovation”: An ongoing update of FDA’s novel new drug approvals of 2011

spotdrugsThe 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 regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. In this function, FDA supports innovation and plays a key role in helping to advance new drug development.

So far in 2011, FDA has approved more than 150 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. 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.
FDA's "Spotlight on Drug Innovation" summarizes the latest NMEs approved in 2011:

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

Drug Name

Active Ingredient

Date

What it’s used for

Datscan

ioflupane i-123

01/14 

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

Natroba

spinosad

01/18

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

Viibryd

vilazodone hydrochloride

01/21

To treat major depressive disorder in adults.
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 

Gadavist

gadobutrol

03/14

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

Benlysta

belimumab

03/10

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 

Yervoy

ipilimumab

3/25

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

Horizant

gabapentin enacarbil

04/06

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

Vandetanib

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 

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 

Tradjenta

linagliptin

05/02

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

Edurant

rilpivirine

05/20

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

Incivek

telaprevir

05/23

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

Dificid

fidaxomicin

05/27

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