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Recent FDA Approvals

2010 Approvals
2009 Approvals
2008 Approvals
2007 Approvals
2006 Approvals
2005 Approvals
2004 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.

Glassia™ – alpha-1-proteinase inhibitor – approved – 7/1/2010

For the treatment of chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor

 

Dulera® – formoterol fumarate; mometasone furoate – approved – 6/22/2010

For the treatment of asthma in patients 12 years and older

 

Jevtana® Kit – cabazitaxel – approved – 6/17/2010

For the treatment of advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel; to be used in combination with prednisone

 

Jalyn™ – dutasteride; tamsulosin hydrochloride – approved – 6/14/2010

For the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate

 

Prolia™ – denosumab – approved – 6/1/2010

For the treatment of postmenopausal women with osteoporosis who are at high risk for fractures

 

Lumizyme™ – alglucosidase alfa – approved – 5/24/2010

For the treatment of patients ages 8 years and older with late-onset Pompe disease

 

Natazia™ – dienogest; estradiol valerate – approved – 5/6/2010

For oral contraception

 

Vimovo™ – esomeprazole magnesium; naproxen – approved – 4/30/2010

To relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of stomach ulcers in patients at risk

 

Zortress® – everolimus – approved – 4/20/2010

To  prevent transplant rejection of kidney transplant

 

Asclera™ – polidocanol – approved 3/30/2010

For the treatment of small types of varicose veins when the aim of treatment is to improve appearance

 

Carbaglu® – carglumic acid – approved 3/18/2010

For the treatment of N-acetylglutamate synthase (NAGS) deficiency

 

Vpriv™ – velaglucerase alfa – approved 2/26/2010

For the treatment of children and adults with Type I Gaucher disease

 

Prevnar 13™ – pneumococcal 13-valent vaccine – approved 2/24/2010

For the prevention of invasive disease caused by 13 different serotypes of Streptococcus pneumonia

 

Xiaflex® – collagenase clostridium histolyticum – approved 2/2/2010

For the treatment of Dupuytren's contracture

 

Victoza® – liraglutide – approved 1/25/2010

For the treatment of type 2 diabetes

 

Ampyra™ – dalfampridine – approved 1/22/2010

To improve walking in patients with multiple sclerosis

 

Actemra® – tocilizumab – approved 1/11/2010

For the treatment of adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes for rheumatoid arthritis



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