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.
Oxylanthanum carbonate
Company: Unicycive Therapeutics, Inc.
Treatment for: Hyperphosphatemia of Renal Failure
Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent in development for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis.
- Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis - June 30, 2025
- Unicycive Therapeutics Announces U.S. FDA Acceptance of the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis - November 11, 2024
- Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis - September 3, 2024
Cytisinicline
Company: Achieve Life Sciences, Inc.
Treatment for: Smoking Cessation
Cytisinicline is a nicotinic acetylcholine receptor partial agonist in development as a treatment of nicotine dependence for smoking cessation in adults.
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 Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye Disease - June 17, 2025
- 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
Sebetralstat
Company: KalVista Pharmaceuticals, Inc.
Treatment for: Hereditary Angioedema
Sebetralstat is an oral plasma kallikrein inhibitor in development for the on-demand treatment of hereditary angioedema attacks in adults and pediatric patients aged 12 years and older.
- KalVista Pharmaceuticals Announces FDA Will Not Meet PDUFA Goal Date for Sebetralstat NDA for Hereditary Angioedema Due to FDA Resource Constraints - June 13, 2025
- KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema - September 3, 2024
- KalVista Submits New Drug Application to FDA for Sebetralstat as First Oral On-Demand Treatment for Hereditary Angioedema - June 18, 2024
Brimochol PF (brimonidine tartrate and carbachol) Ophthalmic Solution
Company: Tenpoint Therapeutics, Ltd.
Treatment for: Presbyopia
Brimochol PF (brimonidine tartrate and carbachol) is an alpha-adrenergic agonist and cholinomimetic combination in development for the treatment of presbyopia.
Linerixibat
Company: GSK plc
Treatment for: Primary Biliary Cholangitis
Linerixibat is an ileal bile acid transporter (IBAT) inhibitor in development for the treatment of cholestatic pruritus in patients with primary biliary cholangitis.
Ziftomenib
Company: Kura Oncology, Inc. and Kyowa Kirin Co., Ltd.
Treatment for: Acute Myeloid Leukemia
Ziftomenib is an oral menin inhibitor in development for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation.
Sevabertinib
Company: Bayer
Treatment for: Non Small Cell Lung Cancer
Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) in development for the treatment of HER2-mutant non-small cell lung cancer.
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 “Path Forward” Despite Disappointing Delay for Ultra-Rare Barth Syndrome - May 29, 2025
- 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
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 Biologics License Application for Patients with Previously Treated Locally Advanced or Metastatic EGFRMutated Non-Small Cell Lung Cancer Voluntarily Withdrawn - May 29, 2025
- 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
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.
- Otsuka Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN) - May 27, 2025
- Otsuka Files Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy - March 31, 2025
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.
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.
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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