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).
- Takeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis (EoE) - September 20, 2023
- Takeda Receives Complete Response Letter from the U.S. FDA for TAK-721 - December 21, 2021
- U.S. Food and Drug Administration Accepts New Drug Application for Review, Grants Priority Review for Takeda’s TAK-721 (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis - December 15, 2020
Bimekizumab
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.
- UCB Provides Update on U.S. Regulatory Review of Bimekizumab - September 19, 2023
- UCB Provides Update on U.S. FDA Review of the Biologics License Application for Bimekizumab - June 26, 2023
- Update on U.S. FDA Review of Biologics License Application (BLA) for Bimekizumab - Complete Response Letter - May 13, 2022
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.
- FDA Issues Complete Response Letter for neffy® (epinephrine nasal spray) New Drug Application with Request for Additional Study - September 19, 2023
- ARS Pharmaceuticals Announces PDUFA Date Extension for neffy® (epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis - June 20, 2023
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).
Resmetirom
Company: Madrigal Pharmaceuticals, Inc.
Treatment for: Nonalcoholic Steatohepatitis
Resmetirom is a thyroid hormone receptor (THR) β-selective agonist in development for the treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis.
- Madrigal Pharmaceuticals Announces NDA Acceptance and Priority Review of the New Drug Application for Resmetirom for the Treatment of NASH with Liver Fibrosis - September 13, 2023
- Madrigal Pharmaceuticals Completes Submission of New Drug Application Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis - July 17, 2023
- Madrigal Pharmaceuticals Announces Rolling Submission of New Drug Application to U.S. FDA Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis - June 30, 2023
Tovorafenib
Company: Day One Biopharmaceuticals
Treatment for: Low-Grade Glioma
Tovorafenib is a type II pan-RAF kinase inhibitor in development for the treatment of pediatric low-grade glioma.
- Day One Announces Updated FIREFLY-1 Data for Tovorafenib and Completion of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG) - September 11, 2023
- Day One Announces New FIREFLY-1 Data for Tovorafenib (DAY101) and Initiation of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma - June 4, 2023
Ensifentrine
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.
- Aquestive Therapeutics Receives FDA Acceptance Of New Drug Application (NDA) For Libervant (Diazepam) Buccal Film In Pediatric Patients And Assignment Of Prescription Drug User Fee Act (PDUFA) Date - September 11, 2023
- Aquestive Therapeutics Receives FDA Tentative Approval for Libervant (diazepam) Buccal Film - August 31, 2022
- Aquestive Therapeutics Receives Notification from FDA that It Will Not Be Ready to Take Action by December 23, 2021 for the Company’s NDA for Libervant (diazepam) Buccal Film - December 20, 2021
- Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film - July 19, 2021
- Aquestive Therapeutics Resubmits New Drug Application for Libervant (diazepam) Buccal Film - June 24, 2021
- Aquestive Therapeutics Receives Complete Response Letter from FDA for Libervant (diazepam) Buccal Film for Management of Seizure Clusters - September 25, 2020
- Aquestive Therapeutics Announces U.S. Food and Drug Administration Filing Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film - February 10, 2020
- Aquestive Therapeutics Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Libervant (diazepam) Buccal Film for Management of Seizure Clusters - December 2, 2019
Mavorixafor
Company: X4 Pharmaceuticals
Treatment for: WHIM Syndrome
Mavorixafor is a CXCR4 antagonist in development for the treatment of WHIM syndrome.
Crovalimab
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).
Imetelstat
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).
- Geron Announces PDUFA Date for Imetelstat NDA in Lower Risk MDS - August 22, 2023
- Geron Announces FDA Acceptance of New Drug Application for Imetelstat for the Treatment of Lower Risk MDS - August 21, 2023
- Geron Announces Submission of New Drug Application to FDA for First-in-Class Telomerase Inhibitor Imetelstat - June 20, 2023
Vonoprazan
Company: Phathom Pharmaceuticals
Treatment for: Erosive Esophagitis
Vonoprazan is an investigational, oral small molecule potassium-competitive acid blocker (P-CAB) in development for the treatment of erosive esophagitis.
- Phathom Pharmaceuticals Announces Submission of Six-Month Stability Data in Support of Erosive GERD New Drug Application for Vonoprazan - August 21, 2023
- Phathom Pharmaceuticals Announces FDA Acceptance of NDA Resubmission for Vonoprazan for Erosive GERD - June 12, 2023
- Phathom Pharmaceuticals Resubmits Vonoprazan Erosive GERD New Drug Application to FDA - May 23, 2023
- Phathom Pharmaceuticals Provides Update on New Drug Application Review of Vonoprazan for Erosive Esophagitis - January 3, 2023
- Phathom Pharmaceuticals Announces FDA Acceptance for Filing of Vonoprazan NDA for the Treatment of Erosive Esophagitis - May 25, 2022
- Phathom Pharmaceuticals Submits Vonoprazan NDA to FDA for the Treatment of Erosive Esophagitis - March 14, 2022
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).
- Basilea Announces Submission of a New Drug Application to the US Food and Drug Administration for its Antibiotic Ceftobiprole - August 4, 2023
- FDA Issues Complete Response Letter for Ceftobiprole - December 30, 2009
- FDA accepts for review the Complete Response submission to ceftobiprole NDA - September 3, 2009
- FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections - November 26, 2008
- FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter - September 15, 2008
- FDA Issues Approvable Letter for Ceftobiprole for Treatment of Complicated Skin Infections - March 18, 2008
- FDA Published Today That It Will Not Hold an Advisory Committee Meeting on Ceftobiprole in the Treatment of Complicated Skin and Skin Structure Infections - February 13, 2008
- Basilea Announces Review of Ceftobiprole NDA at FDA Anti-Infective Drugs Advisory Committee Meeting - January 10, 2008
- U.S. FDA and European EMEA Accept Registration Applications for Ceftobiprole, Novel Anti-MRSA Broad-Spectrum Cephalosporin - July 18, 2007
- New Drug Application Submitted For Novel Investigational AntibioticCeftobiprole - May 18, 2007
Rivoceranib
Company: Elevar Therapeutics, Inc.
Treatment for: Hepatocellular Carcinoma
Rivoceranib is an oral tyrosine kinase inhibitor (TKI) in development for the treatment of hepatocellular carcinoma.
- Elevar Therapeutics Announces FDA Acceptance for Filing of New Drug Application for Rivoceranib in Combination with Camrelizumab as a First-line Treatment for Unresectable Hepatocellular Carcinoma - July 17, 2023
- Elevar Therapeutics Submits New Drug Application to FDA for Combination of Rivoceranib and Camrelizumab as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma - May 17, 2023
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.
- FDA Issues Complete Response Letter for PDP-716 NDA Due to Inspection Findings at Third-Party API Manufacturing Facility - July 13, 2023
- Visiox Pharma Announces FDA Acceptance of New Drug Application for Glaucoma - December 8, 2022
- Visiox Pharma Submits New Drug Application Seeking Approval for First Once-Daily Brimonidine for Glaucoma - October 6, 2022
Zolbetuximab
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).
- Amneal Receives U.S. FDA Complete Response Letter for IPX203 - July 3, 2023
- Amneal Announces U.S. FDA Filing Acceptance of New Drug Application for IPX203 for the Treatment of Parkinson’s Disease - November 11, 2022
- Amneal Announces Submission of New Drug Application to the U.S. FDA for IPX203 for the Treatment of Parkinson’s Disease - August 31, 2022
See also: Generic approvals, New drug approvals, Recent additions to Drugs.com, Alphabetical listing of all new drug applications, FDA approval process
New drug applications archive
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