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[1] FDA 2009  | [2] HC 2010  | [3] HC 2009

FDA Approvals 2010:
[4] Dosage Forms
[5] Withdrawals
 New Drugs - 2010
 Actemra / tocilizumab
Genentech
-- An interleukin-6 inhibitor for moderate to severe rheumatoid arthritis.

 Ampyra / dalfampridine
Acorda Therap.
-- A potassium channel blocker to improve walking in patients with multiple sclerosis.

 Asclera /polidocanol
BioForm Medical
-- An injectable agent for small varicose veins (spider veins and reticular veins).

 Carbaglu /carglumic acid
Orphan Europe
-- A CPS 1 activator for elevated ammonia levels due to N-acetylglutamate synthase deficiency.

 Cysview /hexaminolevulinate
Photocure ASA
-- An optical imaging agent for bladder instillation to detect bladder cancer.

 Ella /ulipristal
Watson
-- A progesterone agonist/antagonist emergency contraceptive.

 Glassia /alpha1-proteinase inhibitor
Kamada
-- Replacement therapy for patients with emphysema due to deficiency of alpha1-proteinase inhibitor.

 Jevtana /cabazitaxel
Sanofi-aventis
-- A microtubule inhibitor for advanced prostate cancer.

 Lastacaft /alcaftadine
Vistakon Pharma.
-- An ophthalmic antihistamine for allergic conjunctivitis.

 Lumizyme /alglucosidase alfa
Genzyme
-- An enzyme needed for muscle function with late-onset Pompe disease.

 Menveo /meningococcal vaccine
Novartis
-- A vaccine to prevent meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in persons 11 to 55 years of age.

 Natazia / estradiol valerate/ dienogest
Bayer HealthCare
-- A four-phasic, 28-day oral contraceptive with two placebo tablets.

 Prevnar 13 /pneumococcal 13-valent conjugate vaccine
Wyeth
-- A vaccine to prevent Streptococcus pneumoniae -related infections in children 6 weeks through 5 years.

 Prolia / denosumab
Amgen
-- A RANK ligand inhibitor for treatment of postmenopausal osteoporosis.

 Provenge / sipuleucel-T
Dendreon
-- Autologous cellular immunotherapy for treatment of advanced prostate cancer.

 Victoza / liraglutide
Novo Nordisk
-- A GLP-1 agonist to improve glucose control in type 2 diabetes.

 VPRIV /velaglucerase alfa
Shire
-- An enzyme replacement therapy for type 1 Gaucher disease.

 Xeomin /incobotulinum-toxinA
Merz Pharms.
-- An acetylcholine release inhibitor and neuromuscular blocking agent for cervical dystonia and blepharospasm.

 Xiaflex /collagenase clostridium histolyticum
Auxilium Pharm.
-- A proteolytic enzyme for treatment of Dupuytren's contracture (a progressive hand disease which affects connective tissue in the palm of the hand).

 Zortress /everolimus
Novartis
-- An immunosuppressant for prevention of organ rejection (kidney transplant).



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