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New Drug Applications

The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.
The purpose of a NDA is to provide enough information to permit the FDA to reach the following key decisions

  • Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks
  • Whether the drug's proposed labeling (package insert) is appropriate and what it should contain
  • Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity

For more information on New Drug Applications, please visit the FDA's How Drugs are Developed and Approved page.

Korsuva (difelikefalin)

Company: Cara Therapeutics, Inc.
Treatment for: Chronic Kidney Disease-Associated Pruritus

Korsuva (difelikefalin) is a selective peripheral kappa opioid receptor agonist in development for the treatment of moderate-to-severe pruritus in hemodialysis patients.

gefapixant

Company: Merck
Treatment for: Cough

Gefapixant is an investigational, orally administered, selective P2X3 receptor antagonist, for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.

bardoxolone

Company: Reata Pharmaceuticals, Inc.
Treatment for: Alport Syndrome

Bardoxolone is an investigational, once-daily, orally administered activator of Nrf2 in development for the treatment of Alport syndrome and autosomal dominant polycystic kidney disease (ADPKD).

FT218 (sodium oxybate)

Company: Avadel Pharmaceuticals plc
Treatment for: Narcolepsy

FT218 (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.

AGN-190584 (pilocarpine) Ophthalmic Solution

Company: Allergan
Treatment for: Presbyopia

AGN-190584 (pilocarpine 1.25%) is an optimized ophthalmic solution formulation of the approved cholinergic muscarinic receptor agonist pilocarpine in development for the treatment of presbyopia.

ruxolitinib Cream

Company: Incyte Dermatology
Treatment for: Atopic Dermatitis, Vitiligo

Ruxolitinib is a JAK1/JAK2 inhibitor formulated for topical application in development for the treatment of atopic dermatitis and vitiligo.

tisotumab vedotin

Company: Genmab A/S and Seagen Inc.
Treatment for: Cervical Cancer

Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) in development for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

SPN-812 (viloxazine hydrochloride)

Company: Supernus Pharmaceuticals, Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

SPN-812 (viloxazine hydrochloride) is a serotonin norepinephrine modulating agent (SNMA) in development as a novel, non-stimulant treatment for attention deficit hyperactivity disorder (ADHD).

maralixibat

Company: Mirum Pharmaceuticals, Inc.
Treatment for: Cholestatic Pruritus in Patients with Alagille Syndrome

Maralixibat is an inhibitor of the apical sodium dependent bile acid transporter (ASBT) in development for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).

aducanumab

Company: Biogen
Treatment for: Alzheimer's Disease

Aducanumab (BIIB037) is an investigational human recombinant monoclonal antibody (mAb) in development for the treatment of early Alzheimer’s disease (AD).

sulopenem

Company: Iterum Therapeutics plc
Treatment for: Bacterial Infection

Sulopenem is an orally bioavailable, broad-spectrum penem β-lactam antibiotic in development for the treatment of infections caused by multi-drug resistant bacteria.

odevixibat

Company: Albireo Pharma, Inc.
Treatment for: Progressive Familial Intrahepatic Cholestasis (PFIC)

Odevixibat is a once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) in development for the treatment of rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome.

Trudhesa (dihydroergotamine mesylate) - formerly INP104

Company: Impel NeuroPharma
Treatment for: Migraine

Trudhesa (dihydroergotamine mesylate) is a nasally administered dihydroergotamine (DHE) formulation in development for the acute treatment of migraine headaches.

Kyzatrex (testosterone undecanoate)

Company: Marius Pharmaceuticals
Treatment for: Hypogonadism -- Male

Kyzatrex (testosterone undecanoate) is a novel, soft gelatin capsule testosterone formulation in development for the treatment of primary and secondary hypogonadism in adult men.

somatrogon

Company: Pfizer Inc.
Treatment for: Pediatric Growth Hormone Deficiency

Somatrogon is an investigational, long-acting human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD).

teplizumab

Company: Provention Bio, Inc.
Treatment for: Prevention of Type 1 Diabetes

Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) in development for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals.

ALKS 3831 (olanzapine and samidorphan)

Company: Alkermes plc
Treatment for: Schizophrenia, Bipolar Disorder

ALKS 3831 (olanzapine and samidorphan) is an investigational, once-daily, oral atypical antipsychotic combination of an established antipsychotic agent (olanzapine) and a novel μ-opioid receptor antagonist (samidorphan) in development for the treatment of schizophrenia and bipolar I disorder.

MydCombi (phenylephrine and tropicamide) Ophthalmic Solution

Company: Eyenovia, Inc.
Treatment for: Pharmacologic Mydriasis

MydCombi (phenylephrine and tropicamide) is a fixed-combination microdose formulation of the approved mydriatics phenylephrine and tropicamide in development for pharmacologic mydriasis in the eye care practitioner’s office.

surufatinib

Company: Hutchison China MediTech Limited
Treatment for: Neuroendocrine Carcinoma

Surufatinib is a novel, oral angio-immuno kinase inhibitor in development for the treatment of pancreatic and non-pancreatic neuroendocrine tumors (“NET”).

See also: Generic approvals, New drug approvals, Recent additions to Drugs.com, Alphabetical listing of all new drug applications, FDA approval process

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New Drug Applications Archive

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2020
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2019
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2018
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2017
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2016
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2015
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2014
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2013
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2012
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2011
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2010
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2009
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2008
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2007
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2006
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2005
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2004
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