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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.

KPI-121 0.25% (loteprednol etabonate)

Company: Kala Pharmaceuticals, Inc.
Treatment for: Dry Eye Disease

KPI-121 0.25% (loteprednol etabonate) is an ophthalmic corticosteroid formulation in development for the temporary relief of signs and symptoms of dry eye disease.


Company: Blueprint Medicines Corporation
Treatment for: Gastrointestinal Stromal Tumor

Avapritinib (formerly known as BLU-285) is a potent and highly selective KIT and PDGFRα inhibitor in development for the treatment of PDGFRα Exon 18 mutant gastrointestinal stromal tumors (GIST) and fourth-line GIST.

FMX103 (minocycline) Topical Foam

Company: Foamix Pharmaceuticals Ltd.
Treatment for: Papulopustular Rosacea

FMX103 is a topical minocycline foam formulation in development for the treatment of moderate-to-severe papulopustular rosacea.


Company: Ultragenyx Pharmaceutical Inc.
Treatment for: Long-Chain Fatty Acid Oxidation Disorders

Triheptanoin is a synthetic triglyceride compound in development for the treatment of long-chain fatty acid oxidation disorders.

ET-105 (lamotrigine)

Company: Eton Pharmaceuticals, Inc.

ET-105 is an oral liquid formulation of lamotrigine in development as an adjunct therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients two years of age and older.


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

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


Company: Epizyme, Inc.
Treatment for: Epithelioid Sarcoma

Tazemetostat is an oral, first-in-class, EZH2 inhibitor in development for the treatment of patients with metastatic or locally advanced epithelioid sarcoma.

elexacaftor, ivacaftor and tezacaftor

Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis

Elexacaftor (VX-445), tezacaftor and ivacaftor is a triple combination regimen in development for the treatment of cystic fibrosis.


Company: Novartis
Treatment for: Sickle Cell Anemia

Crizanlizumab (SEG101) is an investigational P-selectin inhibitor in development for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD).

enfortumab vedotin

Company: Astellas and Seattle Genetics
Treatment for: Urothelial Carcinoma

Enfortumab vedotin is a Nectin-4 targeted antibody-drug conjugate (ADC) in development for the treatment of patients with locally advanced or metastatic urothelial cancer.


Company: Sanofi
Treatment for: Multiple Myeloma

Isatuximab is an investigational monoclonal antibody targeting a specific epitope on the CD38 receptor in development for the treatment of relapsed/refractory multiple myeloma (RRMM).

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).

Talicia (amoxicillin, omeprazole and rifabutin) Capsules

Company: RedHill Biopharma Ltd.
Treatment for: Helicobacter pylori Infection

Talicia (RHB-105) is a fixed-dose combination of two antibiotics, rifabutin, and amoxicillin, and a proton pump inhibitor (PPI), omeprazole, in development for the treatment of Helicobacter pylori infection.

Fintepla (fenfluramine)

Company: Zogenix, Inc.
Treatment for: Dravet Syndrome

Fintepla (ZX008, low-dose fenfluramine) is an amphetamine derivative in development for the treatment of seizures associated with Dravet syndrome.

Edsivo (celiprolol)

Company: Acer Therapeutics Inc.
Treatment for: Vascular Ehlers-Danlos Syndrome

Edsivo (celiprolol) is a β-blocker (β1-andrenoceptor antagonist with partial β2 agonist activity) in development for the treatment of vascular Ehlers-Danlos syndrome (vEDS).

Ryaltris (mometasone furoate and olopatadine hydrochloride) Nasal Spray

Company: Glenmark Pharmaceuticals, Inc.
Treatment for: Allergic Rhinitis

Ryaltris (mometasone and olopatadine) is an investigational steroid and antihistamine fixed-dose combination nasal spray in development as a treatment for seasonal allergic rhinitis (SAR) in patients 12 years of age and older.

See also: Generic Approvals, New Drug Approvals, Recent Additions to, Alphabetical Listing of all New Drug Applications, FDA Approval Process

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