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Alphabetical Listing of all New Drug Applications

(galeterone)

(emtricitabine and tenofovir alafenamide)

(Lercanidipine)

(gevokizumab)

(lixivaptan)

(Bifeprunox)

(tivozanib)

(idebenone)
Treatment for: Duchenne Muscular Dystrophy

(obeticholic acid)

(emtricitabine, rilpivirine and tenofovir alafenamide)

(rociletinib)

(Gepirone ER)

(naproxcinod)
Treatment for: Duchenne Muscular Dystrophy

(ceftobiprole)

(cladribine)

(etelcalcetide)

(Bilastine)

(uridine triacetate)

(Satraplatin)

(rapastinel)

(migalastat)

(Tibolone)

(solithromycin)
Treatment for: Community Acquired Bacterial Pneumonia

(loratadine and montelukast)

(pacritinib)
Treatment for: Myelofibrosis

(dapagliflozin and saxagliptin)

(Garenoxacin)

(sofosbuvir and velpatasvir)

(ocrelizumab)

(venetoclax)

(Parecoxib)

(insulin glargine and lixisenatide)

(crisaborole)

(sarilumab)

(Tazarotene)

(baricitinib)

(eteplirsen)
Treatment for: Duchenne Muscular Dystrophy

(brodalumab)

(plecanatide)

(corifollitropin alfa)

(motavizumab)

(Iclaprim)

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

(metadoxine)

(delafloxacin)

(nebivolol and valsartan)

(lifitegrast)
Treatment for: Dry Eye Disease

(tafamidis)
Treatment for: Transthyretin Familial Amyloid Polyneuropathy

(dasabuvir, ombitasvir and ritonavir)

(brincidofovir)
Treatment for: Ebola Virus Disease

(toremifene)

(ridaforolimus)

(defibrotide)
Treatment for: Hepatic Veno-Occlusive Disease

(entrectinib)

(deflazacort)
Treatment for: Duchenne Muscular Dystrophy

(brivaracetam)

Abilify Digital (aripiprazole)

ABP 501 (adalimumab)

ADL5859

Advexin (p53 tumor suppressor therapy)

ALO-02 (naltrexone and oxycodone)

Amphora

Ampligen (rintatolimod)
Treatment for: Chronic Fatigue Syndrome

Androxal (enclomiphene)

Anthim (obiltoxaximab)

Arcoxia (etoricoxib)

Arxxant (ruboxistaurin mesylate)
Treatment for: Diabetic Retinopathy

Arymo ER (morphine sulfate)

Axanum (aspirin and esomeprazole)

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)

CT-P13

Davanat
Treatment for: Targeted Drug Delivery

DB289 (pafuramidine)

Dextenza (dexamethasone)

Dimericine (T4N5 Liposome Lotion)

Dolizem (diltiazem hydrochloride)

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)

Firdapse (amifampridine phosphate)
Treatment for: Lambert Eaton Myasthenic Syndrome (LEMS); Congenital Myasthenic Syndromes (CMS)

Flutiform (formoterol and fluticasone)

Fluviral (influenza vaccine)

Galvus (vildagliptin)

Genasense (oblimersen sodium)

Gencaro (bucindolol)

Heplisav (hepatitis b adult vaccine)

HyQ (immune globulin and recombinant human hyaluronidase)

Imagify (perflubutane)

IMGN529

Indiplon (NBI-34060)

Intrinsa (testosterone)
Treatment for: Female Sexual Dysfunction

JZP-6 (sodium oxybate)

Kiacta (eprodisate)
Treatment for: Amyloid A Amyloidosis

Kovaltry (factor VIII (recombinant))

KRN5500
Treatment for: Chronic Chemotherapy Induced Peripheral Neuropathy

KW-6002 (istradefylline)

Kynapid (vernakalant)

Kyndrisa (drisapersen)
Treatment for: Duchenne Muscular Dystrophy

KYTH-105 (setipiprant)

L-MTP-PE (mifamurtide)

LEP-ETU (Liposome Entrapped Paclitaxel )

Levadex (dihydroergotamine)

LibiGel (testosterone)
Treatment for: Hypoactive Sexual Desire Disorder

Linjeta (insulin)

Locilex (pexiganan)
Treatment for: Diabetic Foot Infection

LPCN 1021 (testosterone)

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

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 )

MuGard

Naturlose (tagatose)

NKTR-181

NOV-205

Nuplazid (pimavanserin)
Treatment for: Parkinson’s Disease Psychosis

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)

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

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)

Vadova (carbidopa and levodopa)

Vesneo (latanoprostene bunod)

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)

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)

ZTlido (lidocaine)

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