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Alphabetical Listing of all New Drug Applications

(galeterone)

(emtricitabine and tenofovir alafenamide)

(Lercanidipine)

(gevokizumab)

(lixivaptan)

(Bifeprunox)

(tivozanib)

(elbasvir and grazoprevir)

(daratumumab)

(idebenone)
Treatment for: Duchenne Muscular Dystrophy

(cariprazine)

(obeticholic acid)

(emtricitabine, rilpivirine and tenofovir alafenamide)

(rociletinib)

(Gepirone ER)

(ixazomib)

(naproxcinod)
Treatment for: Duchenne Muscular Dystrophy

(ceftobiprole)

(cladribine)

(etelcalcetide)

(Bilastine)

(Satraplatin)

(Tibolone)

(loratadine and montelukast)

(Garenoxacin)

(Parecoxib)

(Tazarotene)

(eteplirsen)
Treatment for: Duchenne Muscular Dystrophy

(Sugammadex)

(corifollitropin alfa)

(motavizumab)

(Iclaprim)

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

(metadoxine)

(delafloxacin)

(nebivolol and valsartan)

(lifitegrast)
Treatment for: Dry Eye Disease

(drisapersen)
Treatment for: Duchenne Muscular Dystrophy

(tafamidis)
Treatment for: Transthyretin Familial Amyloid Polyneuropathy

(dasabuvir, ombitasvir and ritonavir)

(brincidofovir)
Treatment for: Ebola Virus Disease

(toremifene)

(patiromer)

(ridaforolimus)

(mepolizumab)

(cobimetinib)

(defibrotide)
Treatment for: Hepatic Veno-Occlusive Disease

(asfotase alfa)
Treatment for: Hypophosphatasia

(entrectinib)

(deflazacort)
Treatment for: Duchenne Muscular Dystrophy

(brivaracetam)

(idarucizumab)
Treatment for: Reversal Agent for Pradaxa

ADL5859

Advexin (p53 tumor suppressor therapy)

ALO-02 (naltrexone and oxycodone)

Ampligen (rintatolimod)
Treatment for: Chronic Fatigue Syndrome

Androxal (enclomiphene)

Anthim (obiltoxaximab)

Arcoxia (etoricoxib)

Aristada (aripiprazole lauroxil)

Arxxant (ruboxistaurin mesylate)
Treatment for: Diabetic Retinopathy

AuriPro (ciprofloxacin)

AVP-825 (sumatriptan)

Axanum (aspirin and esomeprazole)

Belbuca (buprenorphine hydrochloride)

BHR-100 (progesterone)

BiovaxID

Bonefos (clodronate)

BromSite (bromfenac)

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)

Comfyde (carisbamate)

Coprexa (tetrathiomolybdate)

CorVue (binodenoson)

Davanat
Treatment for: Targeted Drug Delivery

DB289 (pafuramidine)

Dimericine (T4N5 Liposome Lotion)

Dolizem (diltiazem hydrochloride)

Dyanavel XR (amphetamine)
Treatment for: ADHD

Emezine (prochlorperazine)

Enhanze SC (recombinant human hyaluronidase)
Treatment for: Drug Delivery

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

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

Kovaltry (factor VIII (recombinant))

KRN5500

KW-6002 (istradefylline)

Kynapid (vernakalant)

L-MTP-PE (mifamurtide)

Laviv (azfibrocel-T)
Treatment for: Facial Wrinkles

LEP-ETU (Liposome Entrapped Paclitaxel )

Levadex (dihydroergotamine)

LibiGel (testosterone)
Treatment for: Hypoactive Sexual Desire Disorder

Linjeta (insulin)

Locilex (pexiganan)
Treatment for: Diabetic Foot Infection

Lucassin (terlipressin)
Treatment for: Hepatorenal Syndrome

Lumigan Timolol (bimatoprost and timolol )

Luveniq (voclosporin)

LX1033

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

MM-398 (irinotecan liposomal)

MorphaBond ER (morphine sulfate)

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

Narcan (naloxone)

Naturlose (tagatose)

NKTR-181

NOV-205

Onco TCS (vincristine sulfate liposomes injection)

Onconase (ranpirnase)

Onrigin (laromustine)

Opaxio (paclitaxel poliglumex)

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)

Rayaldee (calcifediol)

Reloxin (botulinum toxin type A)
Treatment for: Aesthetics

Remoxy (oxycodone)

Reolysin (pelareorep)

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

Saforis (glutamine)

Sanvar (vapreotide acetate)

SD-809 (deutetrabenazine)

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

TAS-102 (tipiracil hydrochloride and trifluridine)

Tcelna (imilecleucel-T)

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

TNX-102 (cyclobenzaprine hydrochloride)

ToprolXL/Hydrochlorothiazide (metoprolol succinate and hydrochlorothiazide)

Translarna (ataluren)
Treatment for: Duchenne Muscular Dystrophy

Trizytek (liprotamase)

Uptravi (selexipag)

Vadova (carbidopa and levodopa)

Virulizin

Vitaros (alprostadil)

Viviant (bazedoxifene)

WC 3016

Xadago (safinamide)

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

Xinlay (atrasentan)

Xtampza ER (oxycodone)

Xyfid (uracil)

Yondelis (trabectedin)

Yosprala (aspirin and omeprazole)

Zalbin (albinterferon alfa-2b)

Zalviso (sufentanil)

Zarnestra (tipifarnib)

Zensana (ondansetron HCl)

Zimulti (rimonabant)

Zinbryta (daclizumab high-yield process)

ZMapp
Treatment for: Ebola Virus Disease

ZS-9 (sodium zirconium cyclosilicate)

Ztilido (lidocaine)

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