FDA’s “Spotlight on Drug Innovation”-An ongoing update of novel new drug approvals in 2011

As an ongoing update, FDA has brought out a list of new molecular entities approved in 2011 under the project titled: "Spotlight on Drug Innovation".

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.
  
Here is a glimpse of the NMEs approved in 2011...check it out!!

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
Potiga	ezogabine	06/13	For use as an add-on medication to treat seizures associated with epilepsy in adults. Press Release

Posted in: 2011 NME approvals,USFDA drug approvals