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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.

Olinvo (oliceridine) Injection

Company: Trevena, Inc.
Treatment for: Pain

Olinvo (oliceridine) is a G protein biased ligand of the mu opioid receptor, a new class of opioid receptor modulator in development for the treatment of moderate-to-severe acute pain.

Bryhali (halobetasol propionate) Lotion - formerly Jemdel

Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis

Bryhali (halobetasol propionate) is a high-potency topical steroid formulation in development for the treatment of plaque psoriasis.

siponimod

Company: Novartis
Treatment for: Multiple Sclerosis

Siponimod is an investigational, sphingosine-1-phosphate receptor modulator in development for the treatment of secondary progressive multiple sclerosis.

Barhemsys (amisulpride) Injection - formerly Baremsis

Company: Acacia Pharma
Treatment for: Nausea/Vomiting -- Postoperative

Barhemsys (amisulpride) is a dopamine antagonist in development for the management of post-operative nausea & vomiting (PONV).

selinexor

Company: Karyopharm Therapeutics Inc.
Treatment for: Multiple Myeloma

Selinexor (KPT-330) is a first in class Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist in development for the treatment of patients with penta-refractory multiple myeloma.

Feraccru (ferric maltol)

Company: Shield Therapeutics plc
Treatment for: Iron Deficiency

Feraccru (ferric maltol) is a non-salt formulation of ferric iron in development for the treatment of iron deficiency.

lumateperone

Company: Intra-Cellular Therapies, Inc.
Treatment for: Schizophrenia

Lumateperone is first-in-class antipsychotic in development for the treatment of schizophrenia.

Valtoco (diazepam) Nasal Spray

Company: Neurelis, Inc.
Treatment for: Epilepsy

Valtoco (diazepam) is an investigational benzodiazepine nasal spray formulation in development for the treatment of epilepsy cluster seizures.

erdafitinib

Company: Janssen Pharmaceuticals, Inc.
Treatment for: Urothelial Carcinoma

Erdafitinib is an investigational, once-daily oral pan-fibroblast growth factor receptor (FGFR) in development for the treatment of patients with locally advanced or metastatic urothelial cancer.

tenapanor

Company: Ardelyx, Inc
Treatment for: Irritable Bowel Syndrome

Tenapanor is a first-in-class, small-molecule inhibitor of gastrointestinal NHE3 in development for the treatment of patients with irritable bowel syndrome with constipation (IBS-C).

Inbrija (levodopa) Inhalation Powder

Company: Acorda Therapeutics, Inc.
Treatment for: Parkinson's Disease

Inbrija (levodopa) is an oral inhalation formulation of the approved drug levodopa in development as a treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.

esketamine Nasal Spray

Company: Janssen Pharmaceuticals, Inc.
Treatment for: Depression

Esketamine is a rapid acting, investigational glutamate receptor modulator antidepressant in development for use in patients with treatment-resistant depression.

dasotraline

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

Dasotraline is a dual dopamine and norepinephrine reuptake inhibitor (DNRI) in development for the treatment of attention deficit hyperactivity disorder (ADHD).

Waylivra (volanesorsen)

Company: Akcea Therapeutics, Inc.
Treatment for: Familial Chylomicronemia Syndrome

Waylivra (volanesorsen) is an antisense oligonucleotide apolipoprotein C-III (ApoC-III) inhibitor in development for the treatment of familial chylomicronemia syndrome (FCS).

stannsoporfin

Company: Mallinckrodt plc
Treatment for: Hyperbilirubinemia

Stannsoporfin is a heme oxygenase inhibitor in development for the treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice.

Esmya (ulipristal acetate)

Company: Allergan plc
Treatment for: Uterine Fibroids

Esmya (ulipristal acetate) is an oral selective progesterone receptor modulator (SPRM) in development for the treatment of uterine fibroids.

Gimoti (metoclopramide) Nasal Spray

Company: Evoke Pharma, Inc.
Treatment for: Gastroparesis

Gimoti (metoclopramide) is an intranasal formulation of the approved drug metoclopramide in development for the treatment of symptoms associated with diabetic gastroparesis in women.

Duobrii (halobetasol propionate and tazarotene) Lotion - formerly IDP-118

Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis

Duobrii (halobetasol propionate and tazarotene) is a corticosteroid and retinoid combination in development for the topical treatment of plaque psoriasis.

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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