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.
Tabelecleucel
Company: Atara Biotherapeutics, Inc.
Treatment for: EBV-Positive Post-Transplant Lymphoproliferative Disease
Tabelecleucel (tab-cel) is an allogeneic, EBV-specific T-cell immunotherapy in development for the treatment of patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease who have received at least one prior therapy.
- Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease - July 17, 2024
- Atara Biotherapeutics Submits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA - May 20, 2024
OX124 (naloxone)
Company: Orexo AB
Treatment for: Opioid Overdose
OX124 (naloxone) is a high-dose nasal formulation of the approved opioid antagonist naloxone in development as a rescue medication for opioid overdose.
- Orexo Receives a Complete Response Letter Regarding the NDA for OX124, a High-Dose Naloxone Rescue Medication in Development for Opioid Overdose - July 17, 2024
- Orexo Submits New Drug Application to FDA for OX124, a High-Dose Rescue Medication for Opioid Overdose - September 19, 2023
- Orexo Submits New Drug Application to FDA for OX124, a High-Dose Rescue Medication for Opioid Overdose - February 3, 2023
ET-400 (hydrocortisone) Oral Solution
Company: Eton Pharmaceuticals, Inc.
Treatment for: Adrenocortical Insufficiency
ET-400 (hydrocortisone) is a proprietary, room temperature stable, oral solution formulation of the approved glucocorticoid hydrocortisone in development for use in children.
Vanzacaftor, tezacaftor and deutivacaftor
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis
Vanzacaftor/tezacaftor/deutivacaftor is a next-in-class, once daily triple combination therapy (vanza triple) in development for the treatment of cystic fibrosis.
Mirdametinib
Company: SpringWorks Therapeutics, Inc.
Treatment for: Neurofibromatosis
Mirdametinib is an investigational MEK inhibitor in development for the treatment of patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN).
- SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN - July 1, 2024
- SpringWorks Therapeutics Initiates Rolling Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN - March 4, 2024
Patritumab deruxtecan
Company: Daiichi Sankyo and Merck
Treatment for: Non Small Cell Lung Cancer
Patritumab deruxtecan (HER3-DXd) is a first-in-class HER3 directed DXd antibody drug conjugate in development for the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer.
- Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer - June 26, 2024
- Patritumab Deruxtecan Granted Priority Review in the U.S. for Certain Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer - December 22, 2023
ABBV-951 (foscarbidopa and foslevodopa)
Company: AbbVie Inc.
Treatment for: Parkinson's Disease
ABBV-951 (foscarbidopa/foslevodopa) is a solution of carbidopa and levodopa prodrugs for continuous subcutaneous delivery that is being investigated for the treatment of motor fluctuations in patients with advanced Parkinson's disease.
- AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa) - June 25, 2024
- AbbVie Provides Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa) New Drug Application - March 22, 2023
- AbbVie Submits New Drug Application to U.S. FDA for Investigational ABBV-951 (Foscarbidopa/Foslevodopa) for the Treatment of Advanced Parkinson's Disease - May 20, 2022
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.
- Iterum Therapeutics Receives FDA Acceptance of Resubmission of NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections - May 31, 2024
- Iterum Therapeutics Resubmits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem - April 29, 2024
- Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem - July 27, 2021
- Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem - January 25, 2021
- Iterum Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem - November 30, 2020
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.
- U.S. FDA Acknowledges Astellas' Resubmission of Biologics License Application for Zolbetuximab and Sets New Action Date - May 30, 2024
- Astellas Provides Update on Zolbetuximab Biologics License Application in U.S. - January 8, 2024
- Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab Biologics License Application - July 6, 2023
Cardamyst (etripamil) Nasal Spray
Company: Milestone Pharmaceuticals Inc.
Treatment for: Paroxysmal Supraventricular Tachycardia
Cardamyst (etripamil) is a novel calcium channel blocker nasal spray in development for the treatment of paroxysmal supraventricular tachycardia and atrial fibrillation with a rapid ventricular rate (AFib-RVR).
- Milestone Pharmaceuticals Announces FDA Acceptance of New Drug Application for Cardamyst - May 29, 2024
- Milestone Pharmaceuticals Announces Resubmission of New Drug Application for Etripamil for Treatment in Paroxysmal Supraventricular Tachycardia - March 28, 2024
- Milestone Pharmaceuticals Receives Refusal to File Letter from U.S. FDA for New Drug Application for Etripamil in the Treatment of PSVT - December 26, 2023
- Milestone Pharmaceuticals Announces Submission of New Drug Application to the U.S. FDA for Etripamil - October 24, 2023
TransCon PTH (palopegteriparatide)
Company: Ascendis Pharma, Inc.
Treatment for: Hypoparathyroidism
TransCon PTH (palopegteriparatide) is a prodrug of parathyroid hormone (PTH [1-34]) in development for the treatment of adult patients with hypoparathyroidism.
Prademagene zamikeracel - formerly EB-101
Company: Abeona Therapeutics Inc.
Treatment for: Epidermolysis Bullosa
Prademagene zamikeracel (pz-cel) is an autologous, engineered cell therapy in development for the treatment for patients with recessive dystrophic epidermolysis bullosa.
SPN-830 (apomorphine) Infusion Device
Company: Supernus Pharmaceuticals, Inc.
Treatment for: Hypomobility in Parkinson’s Disease
SPN-830 (apomorphine) is a continuous subcutaneous infusion formulation of the approved dopamine agonist apomorphine in development for the treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD).
- Supernus Provides Regulatory Update for SPN-830 - April 8, 2024
- Supernus Announces SPN-830 Apomorphine Infusion Device NDA Accepted for Review by FDA - November 2, 2023
Elamipretide
Company: Stealth BioTherapeutics Inc.
Treatment for: Barth Syndrome
Elamipretide is a novel mitochondrial tetrapeptide in development for the treatment of Barth syndrome.
Zanidatamab
Company: Jazz Pharmaceuticals plc
Treatment for: Biliary Tract Tumor
Zanidatamab is a biparatopic HER2-targeted bispecific antibody in development for previously-treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC).
Datopotamab deruxtecan
Company: AstraZeneca and Daiichi Sankyo
Treatment for: Non Small Cell Lung Cancer
Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate in development for the treatment of non-small cell lung cancer.
- Datopotamab Deruxtecan Biologics License Application Accepted in the US for Patients with Previously Treated Metastatic HR-Positive, HER2-Negative Breast Cancer - April 2, 2024
- Datopotamab Deruxtecan Biologics License Application Accepted in the US for Patients with Previously Treated Advanced Nonsquamous Non-Small Cell Lung Cancer - February 19, 2024
Reproxalap
Company: Aldeyra Therapeutics, Inc.
Treatment for: Dry Eye Disease
Reproxalap is a first-in-class small-molecule modulator of RASP (reactive aldehyde species) in development for the treatment of signs and symptoms of dry eye disease.
- Aldeyra Therapeutics Announces Clinical Development Plan for Resubmission of New Drug Application for Reproxalap in Dry Eye Disease - March 28, 2024
- Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Dry Eye Disease - November 27, 2023
- Aldeyra Therapeutics Announces Achievement of Statistical Significance for Primary Endpoint and All Secondary Endpoints in Phase 3 INVIGORATE‑2 Trial of Reproxalap in Allergic Conjunctivitis - June 15, 2023
- Aldeyra Therapeutics Announces FDA Acceptance of New Drug Application for Reproxalap for the Treatment of Dry Eye Disease - February 7, 2023
- Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for Reproxalap for the Treatment of Signs and Symptoms of Dry Eye Disease - November 29, 2022
Govorestat
Company: Applied Therapeutics, Inc.
Treatment for: Galactosemia
Govorestat is a central nervous system penetrant Aldose Reductase Inhibitor (ARI) in development for the treatment of galactosemia.
- Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia - March 28, 2024
- Applied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic Galactosemia - February 28, 2024
Revumenib
Company: Syndax Pharmaceuticals, Inc.
Treatment for: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Revumenib is a first-in-class menin inhibitor in development for the treatment of relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemias including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), and NPM1-mutant (NPM1m) AML.
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
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.