Alphabetical Listing of all New Drug Applications
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(adenovirus types 4 and 7 live oral vaccine)
(metreleptin)
Treatment for: Metabolic Abnormalities associated with Lipodystrophy
(tafamidis)
Treatment for: Transthyretin Familial Amyloid Polyneuropathy
(bazedoxifene and conjugated estrogens)
(naloxegol)
Treatment for: Opioid-Induced Constipation
Advexin (p53 tumor suppressor therapy)
Afrezza (insulin human [rDNA origin])
Allermist (fluticasone furoate)
Ampligen (poly I:poly C12U)
Treatment for: Chronic Fatigue Syndrome
Anoro Ellipta (umeclidinium bromide and vilanterol)
Arxxant (ruboxistaurin mesylate)
Treatment for: Diabetic Retinopathy
Aveed (testosterone undecanoate)
Bonefos (clodronate)
Treatment for:
Ceplene (histamine dihydrochloride)
Certriad (rosuvastatin calcium and fenofibric acid)
Chemophase (recombinant human hyaluronidase)
Treatment for: Chemoadjuvant
CloniBID (clonidine hydrochloride)
Combidex (ferumoxtran-10)
Treatment for:
Contrave (bupropion and naltrexone)
Davanat
Treatment for: Targeted Drug Delivery
Dimericine (T4N5 Liposome Lotion)
Enhanze SC
Treatment for: Drug Delivery
Exanta (ximelagatran)
Treatment for: Oral Anticoagulation Therapy
Extravan (travoprost and timolol )
Fablyn (lasofoxifene tartrate)
Flutiform (formoterol and fluticasone)
Heplisav (hepatitis b adult vaccine)
IB1001 (factor IX (recombinant))
Iluvien (fluocinolone acetonide)
Injectafer (ferric carboxymaltose)
Intrinsa (testosterone)
Treatment for: Female Sexual Dysfunction
Isolagen Therapy
Treatment for: Wrinkle Correction
Kiacta (eprodisate)
Treatment for: Amyloid A Amyloidosis
Laviv (azfibrocel-T)
Treatment for: Facial Wrinkles
LEP-ETU (Liposome Entrapped Paclitaxel )
LibiGel (testosterone)
Treatment for: Hypoactive Sexual Desire Disorder
Lucassin (terlipressin)
Treatment for: Hepatorenal Syndrome
Lumigan Timolol (bimatoprost and timolol )
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)
MoxDuo (morphine and oxycodone)
MQX-503
Treatment for: Raynaud's Disease
MT 100 (naproxen sodium and metoclopramide HCl)
Mucinex with Codeine (guaifenesin and codeine phosphate )
Natpara (recombinant human parathyroid hormone)
Northera (droxidopa)
Treatment for: Neurogenic Orthostatic Hypotension
Onco TCS (vincristine sulfate liposomes injection)
orBec (beclomethasone dipropionate)
Treatment for: Intestinal Graft-versus-Host Disease (iGVHD)
Preos (parathyroid hormone (PTH 1-84))
Priligy (dapoxetine)
Treatment for: Premature Ejaculation
Prochymal
Treatment for: Graft-versus-Host Disease
Prolacria (diquafosol tetrasodium)
Treatment for: Dry Eye
Pulminiq (cyclosporine)
Treatment for: Lung-Transplant Rejection
Reloxin (botulinum toxin type A)
Treatment for: Aesthetics
RG1068 (synthetic human secretin)
Rhucin (recombinant human C1 esterase inhibitor)
RSR13 (efaproxiral)
Treatment for: Brain Metastases in patients with Breast Cancer
Rytary (carbidopa and levodopa)
Sefelsa (gabapentin)
Treatment for: Menopausal Hot Flashes
SnET2-PDT (Tin ethyl etiopurpurin (SnET2) photodynamic therapy (PDT))
Sparlon (modafinil)
Treatment for: ADHD in Children and Adolescents
SparVax (recombinant Protective Antigen (rPA) anthrax vaccine)
SPD465 (triple-bead mixed amphetamine salts)
Treatment for: ADHD in Adults
ST-246
Treatment for: Exposure to Smallpox Virus
Stedesa (eslicarbazepine acetate)
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)
Viread and Emtriva (tenofovir disoproxil fumarate and emtricitabine)
Xcytrin (motexafin gadolinium)
Treatment for: Lung Cancer Brain Metastases
Xyotax (paclitaxel poliglumex)
