New drug approvals

Drugs Approved for New Purposes or as Novel Formulations in 2009

Generic Name	Traditional Use	New Form	New Use
benzyl alcohol	preservative	5% lotion	head lice
bromocriptine	acromegaly, hyperprolactinemia, Parkinson disease	0.8mg tablet	type 2 diabetes mellitus
calcitriol	secondary hyperparathyroidism, hypocalcemia	0.0003% ointment	psoriasis
capsaicin	muscle or joint pain	8% transdermal patch (Rx)	postherpetic neuralgia
ciprofloxacin	superficial ocular infections	0.2% otic solution	otitis externa
diclofenac	analgesia, ankylosing spondylitis, arthritis. dysmenorrhea, migraine	1.5% solution in DMSO for topical application	osteoarthritis of the knee
guanfacine	hypertension	1mg, 2mg, 3mg, 4mg extended-release tablets	attention deficit hyperactivity disorder
ibuprofen	pain, inflammation, fever	IV solution for administration in health care settings (Rx)	analgesia
ketoprofen	arthritis	12.5mg cinnamon or peppermint flavored oral film (OTC)	minor pain
sildenafil	erectile dysfunction	10mg/12.5mL injection	pulmonary arterial hypertension
sumatriptan	migraine	6mg subcutaneously (needle-free system)	migraine
tadalafil	erectile dysfunction	20mg tablet	pulmonary arterial hypertension
tranexamic acid	hemophilia (post-tooth extraction hemorrhage)	650mg tablet	menorrhagia
treprostinil	pulmonary arterial hypertension (continuous IV infusion)	0.6 mg/mL inhalation	pulmonary arterial hypertension
vigabatrin*	orphan drug for infantile spasms (West syndrome)	500mg tablet	refractory complex partial seizures

New Drugs Licensed in 2009 with Mechanisms Similar to Previously Approved Drugs

Generic Name	Mechanism of Action	2009 FDA Approved Indication	Pharmacologically Similar Agents
abobotulinum toxin type A (botulinum toxin type A neurotoxin complex produced from a proprietary fermentation process)	acetylcholine release inhibitor	Treatment of cervical dystonia and cosmetic treatment of facial lines	onabotulinumtoxinA (botulinum toxin type A)
			rimabotulinumtoxinB (botulinum toxin type B)
asenapine	serotonin, dopamine, alpha adrenergic, and histamine receptor antagonist	• Treatment of manic or mixed episodes associated with bipolar I disorder	clozapine, loxapine, olanzapine, quetiapine
		• Acute treatment of schizophrenia
bepotastine	ophthalmic H1-receptor antagonist and inhibitor of the release of histamine from mast cells	Treatment of itching associated with allergic conjunctivitis	cromolyn, lodoxamine, nedocromil, pemirolast
besifloxacin	ophthalmic fluoroquinolone antibiotic	Treatment of bacterial conjunctivitis	ciprofloxacin, gatifloxacin, levofloxacin, ofloxacin, moxifloxacin
canakinumab	anti-human-IL-1β monoclonal antibody	Treatment of cryopyrin-associated periodic syndromes	anakinra, rilonacept
dexlansoprazole (R-enantiomer of lansoprazole)	(H+,K+)-ATPase inhibitor	• Management of erosive esophagitis	esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole
		• Treatment of heartburn
dronedarone	potassium, calcium, and sodium channel blocker	Therapy of atrial fibrillation or flutter	amiodarone
everolimus	inhibitor of mTOR kinase activity	Treatment of advanced renal cell carcinoma	temsirolimus
febuxostat	xanthine oxidase inhibitor	Management of hyperuricemia	allopurinol
ferumoxytol (superpara-magnetic iron oxide coated in a carbohydrate shell)	hematopoietic	Treatment of iron deficiency anemia associated with chronic kidney disease	iron dextran, iron sucrose, sodium ferric gluconate complex
golimumab	tumor inhibitor necrosis factor α	Treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis	adalimumab, certolizumab, etanercept, infliximab,
iloperidone	dopamine, serotonin, and norepinephrine receptor antagonist	Treatment of schizophrenia	paliperidone, risperidone, ziprasidone
milnacipran	selective serotonin and norepinephrine reuptake inhibitor	Management of fibromyalgia	desvenlafaxine, duloxetine, venlafaxine
ofatumumab	monoclonal antibody against CD20	Treatment of chronic lymphocytic leukemia	rituximab
pazopanib	multi-tyrosine kinase inhibitor	Treatment of advanced renal cell carcinoma	dasatinib, erlotinib, gefitinib, imatinib, lapatinib, nilotinib, sunitinib
pitavastatin	HMG CoA reductase inhibitor	Management of hypercholesterolemia	atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin
pralatrexate	folate analogue metabolic inhibitor	Treatment of relapsed or refractory peripheral T-cell lymphoma	methotrexate, pemetrexed
prasugrel	platelet P2Y12 receptor antagonist	Management of acute coronary syndrome	clopidogrel, ticlopidine
romidepsin	histone deacetylase inhibitor	Treatment of cutaneous T-cell lymphoma	vorinostat
saxagliptin	dipeptidyl peptidase-4 inhibitor	Adjunct treatment for type 2 diabetes mellitus	sitagliptin
telavancin (semi-synthetic vancomycin derivative)	lipoglycopeptide antibacterial	Treatment of complicated skin and skin structure infections caused by susceptible isolates of gram-positive microorganisms	daptomycin, teicoplanin, vancomycin
tolvaptan	vasopressin V2-receptor antagonist	Treatment of hyponatremia	conivaptan

New Pharmacological Drug Classes Introduced in 2009

Pharmacologic Class	First to be Marketed in the U.S.	FDA Approved Indication
endoperoxide/quinoline combination schizontocide	artemether/lumefantrine (coartem)	Treatment of acute, uncomplicated malaria
plasma kallikrein inhibitor	ecallantide (kalbitor)	Treatment of acute attacks of hereditary angioedema
monoclonal antibody against the p40 protein subunit of interleukin-12 and -23	ustekinumab(stelara)	Treatment of moderate to severe plaque psoriasis