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.
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
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 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
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.
IB1001 (N-acetyl-L-leucine)
Company: IntraBio Inc.
Treatment for: Niemann-Pick Disease
IB1001 (N-acetyl-L-leucine) is a modified amino acid in development for the treatment of Niemann-Pick disease type C.
Odronextamab
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Follicular Lymphoma, Diffuse Large B-Cell Lymphoma
Odronextamab is an investigational CD20xCD3 bispecific antibody in development for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL).
Upstaza (eladocagene exuparvovec)
Company: PTC Therapeutics, Inc.
Treatment for: Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency
Upstaza (eladocagene exuparvovec) is a gene replacement therapy for use in the treatment of aromatic L-amino acid decarboxylase deficiency.
DFD-29 (minocycline hydrochloride)
Company: Journey Medical Corporation
Treatment for: Rosacea
DFD-29 (minocycline hydrochloride) is a low-dose, modified-release capsule formulation of minocycline in development for the treatment of inflammatory lesions and erythema of rosacea in adults.
Ensartinib
Company: Xcovery Holdings, Inc.
Treatment for: Non-Small Cell Lung Cancer
Ensartinib is an Anaplastic Lymphoma Kinase (ALK) inhibitor in development for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).
Lumisight (pegulicianine) for Injection
Company: Lumicell, Inc.
Treatment for: Diagnosis and Investigation
Lumisight (pegulicianine) is an optical imaging agent for the detection of residual cancerous tissue during breast cancer surgery.
- FDA Approves Lumisight (pegulicianine) Optical Imaging Agent to Illuminate Residual Breast Cancer Post-Lumpectomy - April 18, 2024
- Lumicell Announces FDA Advisory Committee’s Positive Recommendation on the Benefit-Risk Profile of Lumisight in the Detection of Cancerous Tissue During Breast Conserving Surgery - March 6, 2024
- Lumicell Announces FDA Acceptance and Priority Review of New Drug Application for Lumisight™ Optical Imaging Agent for Breast Cancer - May 22, 2023
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).
Arimoclomol
Company: Zevra Therapeutics, Inc.
Treatment for: Niemann-Pick Disease
Arimoclomol is an investigational heat shock protein amplifier in development for the treatment of Niemann-Pick disease Type C (NPC).
- Zevra Therapeutics Provides FDA Update On The PDUFA Action Date For Arimoclomol As A Treatment For Niemann-Pick Disease Type C - March 4, 2024
- Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application to the U.S. Food and Drug Administration - December 27, 2023
- Orphazyme Provides Update for Planned NDA Resubmission for Arimoclomol for the Treatment of Niemann-Pick Disease Type C in the United States - February 11, 2022
- Orphazyme Provides Regulatory Update from FDA on Arimoclomol for Niemann-Pick Disease Type C - June 18, 2021
- Orphazyme Announces FDA Acceptance and Priority Review of New Drug Application for Arimoclomol for Niemann-Pick Disease Type C - September 16, 2020
- Orphazyme Completes Rolling Submission of New Drug Application To U.S. FDA for Arimoclomol for Niemann-Pick Disease Type C - July 20, 2020
- Orphazyme Initiates Rolling Submission of New Drug Application for Arimoclomol with US FDA in Niemann-Pick Disease Type C - May 29, 2020
Roluperidone
Company: Minerva Neurosciences, Inc.
Treatment for: Schizophrenia
Roluperidone is a 5-HT2A and sigma2 receptor antagonist in development for the treatment of certain symptoms in patients with schizophrenia.
- Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia - February 27, 2024
- Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia - May 10, 2023
- Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia - December 28, 2022
- Minerva Neurosciences Receives Refusal to File Letter from FDA for its New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia - October 17, 2022
- Minerva Neurosciences Submits New Drug Application to FDA for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia - August 22, 2022
Tevimbra (tislelizumab-jsgr) Injection
Company: BeiGene, Ltd.
Treatment for: Esophageal Carcinoma
Tevimbra (tislelizumab-jsgr) is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor .
- FDA Approves Tevimbra (tislelizumab-jsgr) for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma - March 14, 2024
- BeiGene’s Biologics License Application for Tevimbra (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA - February 27, 2024
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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