New and Generic Drug Approvals by FDA January 15, 2015

Drug Name
Active Ingredient
Dosage Form/Route
Abilify Maintena Kit
aripiprazole
For Suspension, Extended Release;Intramuscular
Acetaminophen
acetaminophen
Suppository;Rectal
Advil Pm
diphenhydramine citrate; ibuprofen
Tablet;Oral
Atralin
tretinoin
Gel;Topical
Atrovent
ipratropium bromide
Spray, Metered;Nasal
Avapro
irbesartan
Tablet;Oral
Banzel
rufinamide
Suspension;Oral
Cafcit
caffeine citrate
Solution;Intravenous
Cafcit
caffeine citrate
Solution;Oral
Colazal
balsalazide disodium
Capsule;Oral
Conzip
tramadol hydrochloride
Capsule, Extended Release;Oral
Creon
pancrelipase (amylase;lipase;protease)
Capsule, Delayed Release;Oral
Dtpa
technetium tc-99m pentetate kit
Injectable;Injection
Femcon Fe
ethinyl estradiol; norethindrone
Tablet, Chewable;Oral
Gattex Kit
teduglutide recombinant
Powder;Subcutaneous
Giazo
balsalazide disodium
Tablet;Oral
Gleostine
lomustine
Capsule;Oral
Heparin Sodium
heparin sodium
Injectable;Injection
Infants' Feverall
acetaminophen
Suppository;Rectal
Janumet
metformin hydrochloride; sitagliptin phosphate
Tablet;Oral
Jevtana Kit
cabazitaxel
Solution;Iv (Infusion)
Kalydeco
ivacaftor
Tablet;Oral
Latuda
lurasidone hydrochloride
Tablet;Oral
Linzess
linaclotide
Capsule;Oral
Lithobid
lithium carbonate
Tablet, Extended Release;Oral
Nicorette
nicotine polacrilex
Gum, Chewing;Buccal
Nicorette (Mint)
nicotine polacrilex
Gum, Chewing;Buccal
Oraverse
phentolamine mesylate
Injectable;Injection
Ponstel
mefenamic acid
Capsule;Oral
Pralidoxime Chloride
pralidoxime chloride
Injectable;Injection
Ravicti
glycerol phenylbutyrate
Liquid;Oral
Simcor
niacin; simvastatin
Tablet, Extended Release;Oral
Tarka
trandolapril; verapamil hydrochloride
Tablet, Extended Release;Oral
Technetium Tc 99m Generator
technetium tc-99m sodium pertechnetate generator
Solution;Intravenous, Oral
Valsartan
valsartan
Tablet;Oral
Valsartan
valsartan
Tablet;Oral
Valsartan
valsartan
Tablet;Oral
Valsartan
valsartan
Tablet;Oral
Valsartan
valsartan
Tablet;Oral
Valsartan
valsartan
Tablet;Oral
Valsartan
valsartan
Tablet;Oral
Valsartan
valsartan
Tablet;Oral
Valsartan
valsartan
Tablet;Oral
Vazculep
phenylephrine hydrochloride
Solution;Iv (Infusion)
Ventavis
iloprost
Solution;Inhalation
Xeloda
capecitabine
Tablet;Oral
Xyzal
levocetirizine dihydrochloride
Solution;Oral
Zanosar
streptozocin
Injectable;Injection
Zometa
zoledronic acid
Injectable;Iv (Infusion)