Alphabetical Listing of all New Drug Applications

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(galeterone)

(Lercanidipine)

(gevokizumab)

(lixivaptan)

(Bifeprunox)

(tivozanib)

(cariprazine)

(Gepirone ER)

(naproxcinod)

(ceftobiprole)

(cladribine)

(Bilastine)

(Satraplatin)

(Tibolone)

(loratadine and montelukast)

(Garenoxacin)

(Parecoxib)

(cangrelor)

(Tazarotene)

(eteplirsen)
Treatment for: Duchenne Muscular Dystrophy

(Sugammadex)

(corifollitropin alfa)

(motavizumab)

(Iclaprim)

(flibanserin)
Treatment for: Hypoactive Sexual Desire Disorder

(triheptanoin)
Treatment for: Glucose Transporter Type-1 Deficiency Syndrome

(budesonide)

(metadoxine)

(delafloxacin)

(donepezil and memantine)

(nebivolol and valsartan)

(cobicistat and darunavir)

(daclatasvir)

(empagliflozin and linagliptin)

(atazanavir and cobicistat)

(ceftolozane and tazobactam)

(lifitegrast)
Treatment for: Dry Eye Disease

(drisapersen)
Treatment for: Duchenne Muscular Dystrophy

(tafamidis)
Treatment for: Transthyretin Familial Amyloid Polyneuropathy

(lamivudine and raltegravir)

(isavuconazole)

(naloxone)

(olodaterol and tiotropium)

(evolocumab)

(ivabradine)

(eluxadoline)

(dasabuvir, ombitasvir and ritonavir)

(adenovirus types 4 and 7 live oral vaccine)

(brexpiprazole)

(brincidofovir)
Treatment for: Ebola Virus Disease

(lenvatinib)

(secukinumab)

(empagliflozin and metformin)

(toremifene)

(patiromer)

(ridaforolimus)

(mepolizumab)

(ivacaftor and lumacaftor)

(avibactam and ceftazidime)

(cobimetinib)

(defibrotide)
Treatment for: Hepatic Veno-Occlusive Disease

(aspirin and esomeprazole)

ACZ885 (canakinumab)

ADL5859

Advexin (p53 tumor suppressor therapy)

Allermist (fluticasone furoate)

Ampligen (rintatolimod)
Treatment for: Chronic Fatigue Syndrome

Androxal (enclomiphene)

Arcoxia (etoricoxib)

Arxxant (ruboxistaurin mesylate)
Treatment for: Diabetic Retinopathy

AVP-825 (sumatriptan)

BHR-100 (progesterone)

BiovaxID

Bonefos (clodronate)
Treatment for:

Calmactin (cilansetron)

Ceplene (histamine dihydrochloride)

Certriad (rosuvastatin calcium and fenofibric acid)

Chemophase (recombinant human hyaluronidase)
Treatment for: Chemoadjuvant

Ciltyri (eplivanserin)

Civanex (zucapsaicin)

CloniBID (clonidine hydrochloride)

Clonicel (clonidine)

Combidex (ferumoxtran-10)
Treatment for:

Comfyde (carisbamate)

Coprexa (tetrathiomolybdate)

CorVue (binodenoson)

Davanat
Treatment for: Targeted Drug Delivery

DB289 (pafuramidine)

Dimericine (T4N5 Liposome Lotion)

Dolizem (diltiazem hydrochloride)

Dyloject (diclofenac sodium)

Emezine (prochlorperazine)

Enhanze SC
Treatment for: Drug Delivery

Envarsus (tacrolimus)

Epiceram

Exanta (ximelagatran)
Treatment for: Oral Anticoagulation Therapy

Exelbine (vinorelbine)

Extravan (travoprost and timolol )

Fablyn (lasofoxifene tartrate)

Flutiform (formoterol and fluticasone)

Fluviral (influenza vaccine)

Galvus (vildagliptin)

Genasense (oblimersen sodium)

Gencaro (bucindolol)

Guaifenesin Combination

Heplisav (hepatitis b adult vaccine)

HyQ

IB1001 (factor IX (recombinant))

Ibrance (palbociclib)

Imagify (perflubutane)

IMGN529

Indiplon (NBI-34060)

Intrinsa (testosterone)
Treatment for: Female Sexual Dysfunction

Isolagen Therapy
Treatment for: Wrinkle Correction

JZP-6 (sodium oxybate)

Kiacta (eprodisate)
Treatment for: Amyloid A Amyloidosis

KRN5500

KW-6002 (istradefylline)

Kynapid (vernakalant)

L-MTP-PE (mifamurtide)

Laviv (azfibrocel-T)
Treatment for: Facial Wrinkles

LBH589 (panobinostat)

LEP-ETU (Liposome Entrapped Paclitaxel )

Levadex (dihydroergotamine)

Levosert (levonorgestrel)

LibiGel (testosterone)
Treatment for: Hypoactive Sexual Desire Disorder

Linjeta (insulin)

Lucassin (terlipressin)
Treatment for: Hepatorenal Syndrome

Lumigan Timolol (bimatoprost and timolol )

Luveniq (voclosporin)

LX1033

Lynparza (olaparib)

Lyxumia (lixisenatide)

Macrilen (macimorelin acetate)

MBI-226 (omiganan pentahydrochloride)
Treatment for: Prevention of catheter-related Bloodstream Infections

ME-344

Mesavance (mesalamine)

Microcyn

Miraxion (eicosapentaenoic acid (EPA))
Treatment for: Huntington's Disease

MK-0524A (niacin ER and laropiprant)

MK-3475

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 )

MuGard

Natpara (recombinant human parathyroid hormone)

Naturlose (tagatose)

NKTR-181

NOV-205

Onco TCS (vincristine sulfate liposomes injection)

Onconase (ranpirnase)

Onrigin (laromustine)

Opdivo (nivolumab)

Orapem (faropenem medoxomil)

Orathecin (rubitecan)

orBec (beclomethasone dipropionate)
Treatment for: Intestinal Graft-versus-Host Disease (iGVHD)

Ostora (calcitonin)

OT-730

Oxyprim (oxypurinol)

Pancrecarb (pancrelipase)

Pargluva (muraglitazar)

Pixuvri (pixantrone)

Plumiaz (diazepam)

PolyHeme (human hemoglobin)

Preos (parathyroid hormone (PTH 1-84))

Prexige (lumiracoxib)

Priligy (dapoxetine)
Treatment for: Premature Ejaculation

Probuphine (buprenorphine)

Prochymal
Treatment for: Graft-versus-Host Disease

Prolacria (diquafosol tetrasodium)
Treatment for: Dry Eye

Pulminiq (cyclosporine)
Treatment for: Lung-Transplant Rejection

Pulzium (tedisamil)

PW2101

Ragwitek (short ragweed pollen allergen extract)

Rapivab (peramivir)

Reloxin (botulinum toxin type A)
Treatment for: Aesthetics

Remoxy (oxycodone)

Replagal (agalsidase alfa)

Restanza (cethromycin)

Retaane (anecortave acetate)

Rextoro (testosterone undecanoate)

Rezonic (casopitant)

RG1068 (synthetic human secretin)

Riquent (abetimus sodium)

RSR13 (efaproxiral)
Treatment for: Brain Metastases in patients with Breast Cancer

Rytary (carbidopa and levodopa)

Saforis (glutamine)

Sanvar (vapreotide acetate)

Savaysa (edoxaban)

Saxenda (liraglutide)

Sefelsa (gabapentin)
Treatment for: Menopausal Hot Flashes

Serdolect (sertindole)

SGX942

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

Sustol (granisetron)

T-Pred (tobramycin and prednisolone)
Treatment for: Ocular Inflammation

Thelin (sitaxsentan)
Treatment for: Pulmonary Arterial Hypertension (PAH)

TNX-102 (cyclobenzaprine hydrochloride)

ToprolXL/Hydrochlorothiazide (metoprolol succinate and hydrochlorothiazide)

Toujeo (insulin glargine [rDNA origin])

Tovaxin

Triferic (ferric pyrophosphate citrate)

Trizytek (liprotamase)

Tuzistra XR

Vadova (carbidopa and levodopa)

Viread and Emtriva (tenofovir disoproxil fumarate and emtricitabine)

Virulizin

Vitaros (alprostadil)

Viviant (bazedoxifene)

WC 3016

Xcytrin (motexafin gadolinium)
Treatment for: Lung Cancer Brain Metastases

Xinlay (atrasentan)

XM02 (filgrastim)

Xtampza ER (oxycodone)

Xyfid (uracil)

Xyotax (paclitaxel poliglumex)

Yondelis (trabectedin)

Yosprala (aspirin and omeprazole)

Zalbin (albinterferon alfa-2b)

Zalviso (sufentanil)

Zarnestra (tipifarnib)

Zensana (ondansetron HCl)

Zimulti (rimonabant)

Ztilido (lidocaine)

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