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