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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.

TAK-721 (budesonide) Oral Suspension

Company: Takeda Pharmaceutical Company Limited
Treatment for: Eosinophilic Esophagitis

TAK-721 (budesonide oral suspension) is a novel mucoadherent topically active oral viscous formulation of budesonide in development as a treatment for eosinophilic esophagitis (EoE).


Company: UCB, Inc.
Treatment for: Plaque Psoriasis

Bimekizumab is an investigational humanized IgG1 monoclonal antibody in development for the treatment of moderate to severe plaque psoriasis in adults.

neffy (epinephrine) Nasal Spray

Company: ARS Pharmaceuticals, Inc.
Treatment for: Anaphylaxis

neffy® (epinephrine) is an intranasal epinephrine formulation in development for the treatment of allergic reactions (Type 1), including anaphylaxis, for adults and children ≥30 kg.

OTL-200 (atidarsagene autotemcel)

Company: Orchard Therapeutics
Treatment for: Metachromatic Leukodystrophy

OTL-200 (atidarsagene autotemcel) is an autologous haematopoietic stem cell (HSC) gene therapy in development for the treatment of metachromatic leukodystrophy (MLD).


Company: Verona Pharma plc
Treatment for: COPD, Maintenance

Ensifentrine is a selective dual inhibitor of the enzymes phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) in development for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Libervant (diazepam) Buccal Film

Company: Aquestive Therapeutics, Inc.
Treatment for: Seizure Clusters

Libervant (diazepam) is a buccal film formulation of the approved benzodiazepine diazepam in development for the management of seizure clusters.


Company: X4 Pharmaceuticals
Treatment for: WHIM Syndrome

Mavorixafor is a CXCR4 antagonist in development for the treatment of WHIM syndrome.


Company: Genentech, Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria

Crovalimab is an investigational, novel anti-C5 recycling monoclonal antibody in development for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).


Company: Geron Corporation
Treatment for: Myelodysplastic Syndrome

Imetelstat is a novel, first-in-class telomerase inhibitor in development for the treatment of transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs).

Cefepime and taniborbactam

Company: Venatorx Pharmaceuticals
Treatment for: Urinary Tract Infection

Cefepime-taniborbactam is an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic in development for the potential treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis.

Avasopasem manganese

Company: Galera Therapeutics, Inc.
Treatment for: Mucositis

Avasopasem manganese is a selective small molecule dismutase mimetic in development for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer (HNC) undergoing standard-of-care treatment.

Ceftobiprole medocaril

Company: Basilea Pharmaceutica Ltd.
Treatment for: Skin and Structure Infection

Ceftobiprole medocaril, the prodrug of the active moiety ceftobiprole, is a cephalosporin antibiotic in development for the treatment of Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

PDP-716 (brimonidine tartrate)

Company: Visiox Pharma, LLC
Treatment for: Glaucoma, Open Angle, Glaucoma/Intraocular Hypertension

PDP-716 (brimonidine tartrate 0.35%) is a once-daily ophthalmic formulation of the approved alpha adrenergic agonist brimonidine in development for the treatment of ocular hypertension and open angle glaucoma.


Company: Astellas Pharma Inc.
Treatment for: Gastric Cancer

Zolbetuximab is an investigational, first-in-class chimeric IgG1 monoclonal antibody targeting Claudin 18.2 (CLDN18.2) in development for the treatment of patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

IPX203 (carbidopa and levodopa)

Company: Amneal Pharmaceuticals, Inc.
Treatment for: Parkinson's Disease

IPX203 (carbidopa/levodopa) is a novel, oral formulation of carbidopa/levodopa (CD/LD) in development for the treatment of Parkinson’s disease (PD).

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

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