Alphabetical Listing of all New Drug Applications
(Dapoxetine)
Treatment for: Premature Ejaculation
(Adenovirus Types 4 and 7 Live Oral Vaccine)
(tesamorelin)
Treatment for: HIV-Associated Lipodystrophy
(mometasone furoate and formoterol fumarate)
(glycopyrrolate)
Treatment for: Pediatric Drooling
XP12B (tranexamic acid)
Treatment for: Menorrhagia
ABthrax (raxibacumab)
Treatment for: Anthrax
Acetavance (intravenous acetaminophen)
Acurox (oxycodone hydrochloride and niacin)
Advexin (p53 tumor suppressor therapy)
Afresa (insulin monomer human [rDNA origin])
Allermist (fluticasone furoate)
Ampligen (poly I:poly C12U)
Treatment for: Chronic Fatigue Syndrome
Aridol (mannitol dry powder for inhalation)
Treatment for: Bronchial Challenge Test
Arxxant (ruboxistaurin mesylate)
Treatment for: Diabetic Retinopathy
Belotero Balance (hyaluronic acid)
Bonefos (clodronate)
Treatment for:
Ceplene (histamine dihydrochloride)
Treatment for: Acute Myeloid Leukemia Remission Maintenance Therapy
Certriad (rosuvastatin calcium and fenofibric acid)
Chemophase (recombinant human hyaluronidase)
Treatment for: Chemoadjuvant
CloniBID (clonidine hydrochloride)
Combidex (ferumoxtran-10)
Treatment for:
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)
Fampridine-SR (4-aminopyridine)
Flutiform (formoterol and fluticasone)
Forteo (teriparatide (rDNA origin))
Gestiva (17-alpha hydroxyprogesterone caproate)
Injectafer (ferric carboxymaltose)
Intermezzo (zolpidem tartrate)
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 (female testosterone gel)
Treatment for: Female Sexual Dysfunction
Lucassin (terlipressin)
Treatment for: Hepatorenal Syndrome
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)
MQX-503
Treatment for: Raynaud's Disease
MT 100 (naproxen sodium and metoclopramide HCl)
Mucinex with Codeine (guaifenesin and codeine phosphate )
Nebido (testosterone undecanoate)
Omapro (omacetaxine mepesuccinate)
Onco TCS (vincristine sulfate liposomes injection)
orBec (beclomethasone dipropionate)
Treatment for: Intestinal Graft-versus-Host Disease (iGVHD)
Preos (parathyroid hormone (PTH 1-84))
Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM(197) Protein))
Prochymal
Treatment for: Graft-versus-Host Disease
Prolacria (diquafosol tetrasodium)
Treatment for: Dry Eye
Pulminiq (cyclosporine)
Treatment for: Lung-Transplant Rejection
Qlaira (dienogest and estradiol valerate)
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
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)
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)
Velac (clindamycin and tretinoin)
Vimovo (naproxen and esomeprazole magnesium)
Viread and Emtriva (tenofovir disoproxil fumarate and emtricitabine)
Xcytrin (motexafin gadolinium)
Treatment for: Lung Cancer Brain Metastases
Xiaflex (collagenase clostridium histolyticum)
Treatment for: Dupuytren's Disease
Xyotax (paclitaxel poliglumex)
Zenvia (dextromethorphan and quinidine)
Treatment for: Pseudobulbar Affect
