Brand/Generic	Company	Description
Afinitor everolimus	Novartis	An oral kinase inhibitor for advanced kidney cancer.
Arzerra ofatumumab	GSK	A monoclonal antibody for chronic lymphocytic leukemia (CLL).
ATryn antithrombin	Ovation Pharm.	An anticoagulant for patients with hereditary antithrombin deficiency.
Bepreve bepotastime	Ista Pharms	An ophthalmic antihistamine for allergic conjunctivitis.
Berinert C1 Esterase Inhibitor	CSL Behring GmbH	A C1 esterase inhibitor (human) for hereditary angioedema.
Besivance besifloxacin	Bausch & Lomb	An ophthalmic suspension for bacterial conjunctivitis.
Cervarix human papillomavirus	GSK	A vaccine to prevent cervical pre-cancers/cancer caused by human papillomavirus types 16 & 18.
Coartem artemether/lumefantrine	Novartis	Combination product for treatment of acute, uncomplicated malaria infections.
Dysport abobotulinumtoxin A	Ipsen Biopharm	A botulinum toxin for cervical dystonia and improvement of facial lines.
Effient prasugrel	Lilly/Daiichi Sankyo	An antiplatelet for use in patients who undergo angioplasty.
Extavia interferon beta-1b	Novartis	An interferon beta for treatment of relapsing forms of multiple sclerosis.
Fanapt iloperidone	Vanda Pharm.	An atypical antipsychotic for schizophrenia.
Folotyn pralatrexate	Allos Therapeutics	A folate analogue metabolic inhibitor for peripheral T-cell lymphoma.
Hiberix haemophilus influenzae b (Hib) vaccine	GSK	A Hib booster dose for children 15 months through 4 years old.
Ilaris canakinumab	Novartis	An interleukin-1 blocker for Cryopyrin-Associated Periodic Syndromes.
Istodax romidepsin	Gloucester Pharm.	A histone deacetylase inhibitor for cutaneous T-cell lymphoma.
Ixiaro Japanese encephalitis vaccine	Intercell Biomedical	A vaccine for prevention of Japanese encephalitis.
Livalo pitavastatin	Kowa Pharm.	An HMG Co-A reductase inhibitor to reduce cholesterol levels.
Multaq dronedarone	Sanofi-Aventis	An antiarrhythmic for atrial fibrillation or atrial flutter.
Onglyza saxagliptin	BMS/AstraZeneca	A DPP-4 inhibitor for control of blood sugar in adults with type 2 diabetes.
RiaSTAP fibrinogen concentrate (human)	CSL Behring	An intravenous fibrinogen product to treat bleeding in patients with congenital fibrinogen deficiency.
Sabril vigabatrin	Lundbeck	An antiepileptic drug for complex partial seizures in adults (tablets) and infantile spasms (oral solution) in children.
Samsca tolvaptan	Otsuka Pharm.	A vasopressin V2-receptor antagonist for treatment of hyponatremia.
Saphris asenapine	Schering-Plough	An atypical antipsychotic for acute treatment of schizophrenia and bipolar I.
Savella milnacipran	Forest Labs	An SNRI for management of fibromyalgia.
Simponi golimumab	Centocor Ortho Biotech	A TNF-alpha blocker for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
Stelara ustekinumab	Centocor Ortho Biotech	A monoclonal antibody for moderate to severe psoriasis.
Ulesfia benzyl alcohol	Sciele Pharma	A 5% lotion for topical treatment of head lice.
Uloric febuxostat	Takeda	A xanthine oxidase inhibitor for chronic management of gout.
Vibativ telavancin	Theravance Inc.	A lipoglycopeptide antibiotic for complicated gram-positive skin infections.
Votrient pazopanib	GSK	A kinase inhibitor for advanced renal cell carcinoma.

Brand/Generic	Company	Description
Adcirca tadalafil	Lilly	New formulation for pulmonary arterial hypertension.
Astepro azelastine	Meda Pharms	New 0.15% nasal spray for seasonal and perennial allergic rhinitis.
Caldolor ibuprofen	Cumberland Pharm.	Injectable formulation for treatment of pain and fever.
Cambia diclofenac	Kowa Pharm.	Oral solution for acute treatment of migraine attacks.
Colcrys colchicine	Mutual Pharma	First FDA-approved formulation of colchicine.
Cycloset bromocriptine	VeroScience LLC	New 0.8 mg tablets for management of type 2 diabetes.
Edluar zolpidem	Orexo AB	Sublingual formulation for insomnia.
Embeda morphine/naltrexone	King Pharma.	Analgesic for around-the-clock management of moderate to severe pain.
Feraheme ferumoxytol	Amag Pharms	Intravenous iron replacement for anemia of chronic kidney disease.
Gelnique oxybutynin	Watson	Topical gel for treatment of overactive bladder.
Intuniv guanfacine	Shire	New extended-release tablets for treatment of ADHD.
Invega Sustenna paliperidone	Janssen	Once-monthly injectable formulation for acute/maintenance treatment of schizophrenia.
Kapidex dexlansoprazole	Takeda	The R-enantiomer of lansoprazole for erosive esophagitis and heartburn associated with non-erosive GERD.
Lamictal ODT lamotrigine	GSK	New orally disintegrating tablets (ODT).
Lamictal XR lamotrigine	GSK	Extended-release formulation for partial onset seizures.
Lipsovir acyclovir/hydrocortisone	Medivir	Topical cream for early treatment of recurrent cold sores.
Metozolv ODT metoclopramide	Salix	Orally disintegrating tablets for symptoms associated with diabetic gastroparesis and short-term treatment of GERD.
Onsolis fentanyl	Meda Pharm.	New buccal soluble film formulation for breakthrough cancer pain.
Pennsaid diclofenac	Covidien	New topical NSAID solution for osteoarthritis of the knee.
Plan B One-Step levonorgestrel	Duramed	New single dose emergency contraceptive.
Prevacid 24HR lansoprazole	Novartis	Over-the-counter PPI for treatment of heartburn.
Sumavel DosePro sumatriptan	Zogenix	New needle-free subcutaneous delivery system for acute treatment of migraines and cluster headaches.
Synvisc-One hylan G-F 20	Genzyme	New single-injection formulation for osteoarthritis of the knee.
Temodar temozolomide	Schering	New intravenous formulation for glioblastoma and anaplastic astrocytoma.
Twynsta telmisartan/amlodipine	Boehringer Ingelheim	New ARB and calcium channel blocker combination for treatment of hypertension.
Tyvaso treprostinil	United Therap	Inhalation formulation for treatment of pulmonary arterial hypertension.
Valturna aliskiren/valsartan	Novartis	New combination direct renin inhibitor plus ARB for hypertension.
Vectical calcitriol	Galderma Labs	Topical ointment for treatment of plaque psoriasis.
Zipsor diclofenac	Xanodyne Pharm	New liquid filled capsule formulation for mild to moderate acute pain.
Zirgan ganciclovir	Sirion Therapeutics	Ophthalmic gel for acute herpetic keratitis (dendritic ulcers).

Brand/Generic	Company	Description
Raptiva efalizumab	Genentech	Voluntary, phased withdrawal (by June 8, 2009) from the market due to potential risk of progressive multifocal leukoencephalopathy (PML).