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.
Troriluzole
Company: Biohaven Ltd.
Treatment for: Spinocerebellar Ataxia
Troriluzole is a glutamate modulator in development for the treatment of adult patients with spinocerebellar ataxia.
Bysanti (milsaperidone)
Company: Vanda Pharmaceuticals Inc.
Treatment for: Bipolar Disorder, Schizophrenia
Bysanti (milsaperidone) is an atypical antipsychotic in development for the treatments of acute bipolar I disorder and schizophrenia.
Aficamten
Company: Cytokinetics, Incorporated
Treatment for: Hypertrophic Cardiomyopathy
Aficamten is a selective, small molecule cardiac myosin inhibitor in development for the treatment of obstructive hypertrophic cardiomyopathy.
Elamipretide
Company: Stealth BioTherapeutics Inc.
Treatment for: Barth Syndrome
Elamipretide is a novel mitochondrial tetrapeptide in development for the treatment of Barth syndrome.
- Stealth BioTherapeutics Announces Delay in FDA Action Date for Barth Syndrome Application for Elamipretide - April 29, 2025
- Stealth BioTherapeutics Announces PDUFA Action Date Extension for Elamipretide to Treat Patients with Barth Syndrome - January 23, 2025
- Stealth BioTherapeutics Announces Positive Vote from FDA Advisory Committee Meeting Supporting Potential Approval of Elamipretide for the Treatment of Barth Syndrome - October 11, 2024
- Stealth Biotherapeutics Announces FDA Acceptance of New Drug Application for Elamipretide for the Treatment of Barth Syndrome - April 8, 2024
- Stealth BioTherapeutics Submits Elamipretide New Drug Application to FDA for Treatment of Barth Syndrome - August 24, 2021
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 Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and Symptoms of Dry Eye Disease - April 3, 2025
- Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease - November 18, 2024
- Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye Disease - October 3, 2024
- 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
Sibeprenlimab
Company: Otsuka Pharmaceutical Co., Ltd.
Treatment for: Immunoglobulin A Nephropathy
Sibeprenlimab is an inhibitor of APRIL (A PRoliferation-Inducing Ligand) in development for the treatment of immunoglobulin A nephropathy.
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).
- FDA Issues Complete Response Letter for Etripamil for PSVT - March 28, 2025
- 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
Apitegromab
Company: Scholar Rock
Treatment for: Spinal Muscular Atrophy
Apitegromab is an investigational muscle-targeted therapy intended to improve motor function in people living with spinal muscular atrophy (SMA) who have been treated with certain existing SMA therapies.
- FDA Grants Priority Review for Biologics License Application (BLA) for Apitegromab as a Treatment for Spinal Muscular Atrophy - March 25, 2025
- Scholar Rock Submits Biologics License Application (BLA) to the U.S. FDA for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) - January 29, 2025
Tolebrutinib
Company: Sanofi
Treatment for: Multiple Sclerosis
Tolebrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor in development for the treatment of non-relapsing secondary progressive multiple sclerosis.
Deramiocel
Company: Capricor Therapeutics
Treatment for: Duchenne Muscular Dystrophy Cardiomyopathy
Deramiocel is an investigational cell therapy in development for the treatment of Duchenne muscular dystrophy cardiomyopathy.
- Capricor Therapeutics Announces FDA Acceptance and Priority Review of its Biologics License Application for Deramiocel to Treat Duchenne Muscular Dystrophy - March 4, 2025
- Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy - January 2, 2025
Depemokimab
Company: GSK plc
Treatment for: Asthma, Chronic Rhinosinusitis With Nasal Polyps
Depemokimab is a long-acting interleukin-5 antagonist in development for the treatment of asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps.
Relacorilant
Company: Corcept Therapeutics Incorporated
Treatment for: Cushing's Syndrome
Relacorilant is a selective cortisol modulator in development for the treatment of patients with endogenous hypercortisolism (Cushing’s syndrome).
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).
- Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma - February 26, 2025
- Regeneron Provides Update on Biologics License Application for Odronextamab - March 25, 2024
- Odronextamab BLA for Treatment of Relapsed/Refractory Follicular Lymphoma (FL) and Diffuse Large B-cell Lymphoma (DLBCL) Accepted for FDA Priority Review - September 29, 2023
Vatiquinone
Company: PTC Therapeutics, Inc.
Treatment for: Friedreich’s Ataxia
Vatiquinone is a first-in-class selective inhibitor of 15-Lipoxygenase in development for the treatment of Friedreich ataxia.
- PTC Therapeutics Announces FDA Acceptance and Priority Review for Vatiquinone NDA for the Treatment of Children and Adults with Friedreich's Ataxia - February 19, 2025
- PTC Therapeutics Announces Vatiquinone NDA Submission to FDA for the Treatment of Children and Adults Living with Friedreich Ataxia - December 19, 2024
Dordaviprone
Company: Chimerix, Inc.
Treatment for: Malignant Glioma
Dordaviprone is a first-in-class, small molecule imipridone in development for the treatment of patients with recurrent H3 K27M-mutant diffuse glioma.
- Chimerix Announces FDA Acceptance and Priority Review of New Drug Application for Dordaviprone as Treatment for Recurrent H3 K27M-Mutant Diffuse Glioma - February 18, 2025
- Chimerix Submits Dordaviprone New Drug Application for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma - December 30, 2024
Linvoseltamab
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Multiple Myeloma
Linvoseltamab is a BCMAxCD3 bispecific antibody in development for the treatment of relapsed/refractory multiple myeloma.
- Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma - February 11, 2025
- Regeneron Provides Update on Biologics License Application for Linvoseltamab - August 20, 2024
- Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review - February 21, 2024
Lerodalcibep
Company: LIB Therapeutics Inc.
Treatment for: High Cholesterol
Lerodalcibep is third-generation PCSK9 inhibitor in development for the treatment of adults with elevated low-density lipoprotein (LDL) cholesterol.
- LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population - February 10, 2025
- LIB Therapeutics Submits a Biologics License Application to FDA for Lerodalcibep for the Treatment of Adults with Elevated LDL-Cholesterol - December 16, 2024
Brensocatib
Company: Insmed Incorporated
Treatment for: Bronchiectasis
Brensocatib is a dipeptidyl peptidase 1 inhibitor in development for the treatment of patients with bronchiectasis.
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.
- Eton Pharmaceuticals Announces Extension of PDUFA Goal Date for ET-400 - February 6, 2025
- Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-400 (Hydrocortisone Oral Solution) - July 15, 2024
- Eton Pharmaceuticals Announces Submission to FDA of New Drug Application for ET-400 (Hydrocortisone Oral Solution) - April 30, 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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