Thirty-seven new molecular entities, vaccines, and blood products won FDA marketing approval last year, up from 34 in the previous year.

Abobotulinumtoxin A for injection (Dysport, Ipsen)
For the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain and for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age

Antithrombin, recombinant, for i.v. infusion (Atryn, GTC Biotherapeutics)
For the prevention of perioperative and peripartum thromboembolic events in patients with hereditary antithrombin deficiency

Artemether–lumefantrine oral tablets (Coartem, Novartis), for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least 5 kg

Asenapine maleate sublingual tablets (Saphris, Organon)
For the acute treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults

Benzyl alcohol lotion (Ulesfia, Sciele)
For the treatment of head lice infestation

Bepotastine besilate ophthalmic solution (Bepreve, Ista)
For the treatment of ocular itching associated with allergic conjunctivitis in patients age 2 years or older

Besifloxacin hydrochloride ophthalmic suspension (Besivance, Bausch & Lomb)
For the treatment of bacterial conjunctivitis

C1 esterase inhibitor, human, for i.v. infusion (Berinert, CSL Behring)
For the treatment of acute abdominal or facial attacks of hereditary angioedema in adults and adolescents

Canakinumab s.c injection (Ilaris, Novartis)
For the treatment of familial cold autoinflammatory syndrome and Muckle-Wells syndrome in patients age 4 years or older

Colchicine oral tablets (Colcrys, AR Scientific)
For the treatment of gout flares and familial Mediterranean fever

Dronedarone hydrochloride oral tablets (Multaq, Sanofi)
For the maintenance of normal heartbeat in certain patients with a history of paroxysmal or persistent atrial fibrillation or atrial flutter

Ecallantide injection (Kalbitor, Dyax)
For the treatment of acute attacks of hereditary angioedema in patients age 16 years or older

Everolimus oral tablets (Afinitor, Novartis)
For the treatment of advanced renal cell carcinoma

Febuxostat oral tablets (Uloric, Takeda)
For the reduction of elevated serum uric acid levels in patients with gout

Ferumoxytol injection (Feraheme, AMAG)
For the treatment of iron deficiency anemia in adults with chronic kidney disease

Fibrinogen concentrate, human, for i.v. infusion (Riastap, CSL Behring)
For the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency

Golimumab injection (Simponi, Centocor)
For the once-monthly treatment of adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis, or active ankylosing spondylitis

Haemophilus b conjugate vaccine solution for i.m. injection (Hiberix, GlaxoSmithKline)
For the prevention of invasive disease caused by Haemophilus influenzae type b in children 15 months through 4 years of age

Human papillomavirus bivalent vaccine, recombinant, suspension for i.m. injection (Cervarix, GlaxoSmithKline)
To protect against cancers caused by infection with human papillomavirus types 16 and 18

Iloperidone oral tablets (Fanapt, Vanda)
For the acute treatment of schizophrenia in adults

Immune globulin, i.v., human liquid (Gammaplex, Bio Products)
For the treatment of patients with primary humoral immunodeficiency

Influenza virus vaccine, inactivated, suspension for i.m. injection (Agriflu, Novartis)
For active immunization of adults 18 years of age or older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine

Interferon beta-1b for s.c. injection (Extavia, Novartis)
For the treatment of relapsing forms of multiple sclerosis

Japanese encephalitis vaccine, inactivated, adsorbed suspension for i.m. injection (Ixiaro, Intercell)
For the prevention of disease caused by Japanese encephalitis virus in persons 17 years of age or older

Milnacipran hydrochloride oral tablets (Savella, Cypress)
For the treatment of fibromyalgia

Ofatumumab for i.v. infusion (Arzerra, GlaxoSmithKline)
For the treatment of chronic lymphocytic leukemia in patients whose cancer does not respond to other chemotherapy

Pancrelipase oral capsules (Creon, Solvay)
For the treatment of pancreatic insufficiency in adults and children with exocrine pancreatic insufficiency resulting from cystic fibrosis or other conditions

Pazopanib hydrochloride oral tablets (Votrient, GlaxoSmithKline)
For the treatment of advanced renal cell carcinoma

Pitavastatin calcium oral tablets (Livalo, Kowa)
For the improvement of cholesterol levels in patients who have not been able to control their dyslipidemia through diet and exercise

Pralatrexate injection (Folotyn, Allos)
For the treatment of peripheral T-cell lymphoma in patients whose disease has returned or not responded to previous therapy

Prasugrel hydrochloride oral tablets (Effient, Eli Lilly)
To reduce the rate of myocardial infarction and stroke in patients with acute coronary syndrome who are undergoing a catheter-based procedure to reopen an occluded coronary artery

Romidepsin for injection (Istodax, Gloucester)
For the treatment of cutaneous T-cell lymphoma in patients who have already received at least one systemic therapy for the disease

Saxagliptin hydrochloride oral tablets (Onglyza, Bristol-Myers Squibb)
To help control blood glucose concentrations in patients with type 2 diabetes

Telavancin hydrochloride for injection (Vibativ, Theravance)
For the treatment of complicated skin and skin-structure infections in adults

Tolvaptan oral tablets (Samsca, Otsuka)
For the treatment of patients with hypervolemic or euvolemic hyponatremia

Ustekinumab for s.c. injection (Stelara, Centocor Ortho Biotech)
For the treatment of severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy

Vigabatrin oral tablets and powder for oral solution (Sabril, Lundbeck)
For the treatment of infantile spasms and as add-on therapy for the treatment of complex partial seizures in adults

From information available on FDA's Web site, January 2010.