Alphabetical Listing of all New Drug Applications
(Dapoxetine)
Treatment for: Premature Ejaculation
Advexin (p53 tumor suppressor therapy)
Allermist (fluticasone furoate)
AllerNase (triamcinolone acetonide)
Ampligen (poly I:poly C12U)
Treatment for: Chronic Fatigue Syndrome
Aquavan (fospropofol disodium)
ArteFill (dermal filler)
Treatment for: Facial Wrinkles
Arxxant (ruboxistaurin mesylate)
Treatment for: Diabetic Retinopathy
Berinert P (C1-esterase inhibitor)
Bijuva (synthetic conjugated estrogens, A)
Bonefos (clodronate)
Treatment for:
Cellegesic (nitroglycerin ointment, 0.4%)
Treatment for: Anal Fissures
Cervarix (human papillomavirus vaccine, AS04 adjuvant-adsorbed)
Chemophase (recombinant human hyaluronidase)
Treatment for: Chemoadjuvant
Cleviprex (clevidipine butyrate)
CloniBID (clonidine hydrochloride)
Combidex (ferumoxtran-10)
Treatment for:
Davanat
Treatment for: Targeted Drug Delivery
Dimericine (T4N5 Liposome Lotion)
Dysport (botulinum toxin type A)
Treatment for: Cervical Dystonia
Embeda (morphine extended-release with sequestered naltrexone hydrochloride)
Enhanze SC
Treatment for: Drug Delivery
Exanta (ximelagatran)
Treatment for: Oral Anticoagulation Therapy
Extravan (travoprost and timolol )
Fablyn (lasofoxifene tartrate)
Flutiform (formoterol and fluticasone)
Gestiva (17-alpha hydroxyprogesterone)
Hexvix (hexaminolevulinate)
Treatment for: Detection of Bladder Cancer
Imagify (perflubutane)
Treatment for: Detection of Coronary Artery Disease
Injectafer (ferric carboxymaltose)
Intermezzo (zolpidem tartrate)
Intrinsa (testosterone)
Treatment for: Female Sexual Dysfunction
Intuniv (guanfacine)
Treatment for: ADHD in Children and Adolescents
Ixiaro (Japanese Encephalitis Virus Vaccine)
Kiacta (eprodisate)
Treatment for: Amyloid A Amyloidosis
LEP-ETU (Liposome Entrapped Paclitaxel )
LibiGel (female testosterone gel)
Treatment for: Female Sexual Dysfunction
Lipsovir (acyclovir and hydrocortisone)
Lumigan Timolol (bimatoprost and timolol )
Marqibo (vincristine sulfate liposomes)
MBI-226 (omiganan pentahydrochloride)
Treatment for: Prevention of catheter-related Bloodstream Infections
Miraxion (eicosapentaenoic acid (EPA))
Treatment for: Huntington's Disease
MK-0524A (niacin ER and laropiprant)
Mozobil (plerixafor)
Treatment for: Stem Cell Mobilization
MQX-503
Treatment for: Raynaud's Disease
MT 100 (naproxen sodium and metoclopramide HCl)
Mucinex with Codeine (guaifenesin and codeine phosphate )
Nebido (testosterone undecanoate)
Onco TCS (vincristine sulfate liposomes injection)
Onconase (ranpirnase)
Treatment for: Mesothelioma
Oral Fludarabine (fludarabine phosphate)
orBec (beclomethasone dipropionate)
Treatment for: Intestinal Graft-versus-Host Disease (iGVHD)
OTG (oxybutynin hydrochloride)
Treatment for: Overactive Bladder
Premarin Vaginal Cream (conjugated estrogens)
Preos (parathyroid hormone (PTH 1-84))
PRO-513 (diclofenac potassium)
Prolacria (diquafosol tetrasodium)
Treatment for: Dry Eye
Pulminiq (cyclosporine)
Treatment for: Lung-Transplant Rejection
Reloxin (botulinum toxin type A)
Treatment for: Aesthetics
Rhucin (recombinant human C1 esterase inhibitor)
RSR13 (efaproxiral)
Treatment for: Brain Metastases in patients with Breast Cancer
SnET2-PDT (Tin ethyl etiopurpurin (SnET2) photodynamic therapy (PDT))
Solzira (gabapentin enacarbil)
Sparlon (modafinil)
Treatment for: ADHD in Children and Adolescents
SPD465 (triple-bead mixed amphetamine salts)
Treatment for: ADHD in Adults
ST-246
Treatment for: Exposure to Smallpox Virus
SYR-322/Actos (alogliptin and pioglitazone)
T-Pred (tobramycin and prednisolone)
Treatment for: Ocular Inflammation
Thelin (sitaxsentan)
Treatment for: Pulmonary Arterial Hypertension (PAH)
ToprolXL/Hydrochlorothiazide (metoprolol succinate and hydrochlorothiazide)
Vadova (carbidopa and levodopa)
Vasovist (gadofosveset trisodium)
Treatment for: Diagnosis of Vascular Disease
Velac (clindamycin and tretinoin)
Viread and Emtriva (tenofovir disoproxil fumarate and emtricitabine)
Xcytrin (motexafin gadolinium)
Treatment for: Lung Cancer Brain Metastases
Xyotax (paclitaxel poliglumex)
Zentase (pancrealipase)
Treatment for: Exocrine Pancreatic Insufficiency
Zenvia (dextromethorphan and low dose quinidine)
Treatment for: Involuntary Emotional Expression Disorder
