Quantcast

Thursday, March 18, 2010

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

Free Books, powerpoint presentations, teaching tools and resources and drug information