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.
sparsentan
Company: Travere Therapeutics, Inc.
Treatment for: IgA Nephropathy
Sparsentan is a Dual Endothelin Angiotensin Receptor Antagonist (DEARA) in development for the treatment of IgA nephropathy (IgAN).
Furoscix (furosemide)
Company: scPharmaceuticals, Inc.
Treatment for: Heart Failure
Furoscix (furosemide) is a subcutaneous formulation of the approved diuretic furosemide delivered via a wearable, pre-programmed on-body drug delivery system. Furoscix is in development for treatment of congestion in patients with heart failure, and has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to congestion.
- scPharmaceuticals Inc. Announces FDA Acceptance of Furoscix New Drug Application - May 16, 2022
- scPharmaceuticals Inc. Announces Resubmission of Furoscix New Drug Application - April 11, 2022
- scPharmaceuticals Inc. Receives Complete Response Letter from FDA for Furoscix - December 7, 2020
- scPharmaceuticals Announces FDA Acceptance of Furoscix New Drug Application Resubmission - July 27, 2020
- scPharmaceuticals Announces Furoscix NDA Resubmission - July 1, 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.
lecanemab
Company: Biogen Inc. and Eisai Co., Ltd.
Treatment for: Alzheimer's Disease
Lecanemab is an investigational humanized monoclonal antibody in development for the treatment of Alzheimer’s disease (AD).
- Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer’s Disease Under the Accelerated Approval Pathway - May 9, 2022
- Eisai Initiates Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab (BAN2401) for Early Alzheimer's Disease Under the Accelerated Approval Pathway - September 27, 2021
surufatinib
Company: Hutchison China MediTech Limited
Treatment for: Neuroendocrine Carcinoma
Surufatinib is a novel, oral angio-immuno kinase inhibitor in development for the treatment of pancreatic and non-pancreatic neuroendocrine tumors (“NET”).
- Hutchmed Receives Complete Response Letter from the U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors - May 4, 2022
- U.S. FDA Accepts Filing of Hutchmed’s NDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors - July 1, 2021
- Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors - December 28, 2020
zuranolone
Company: Sage Therapeutics, Inc.
Treatment for: Major Depressive Disorder, Postpartum Depression
Zuranolone is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM) in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
toripalimab
Company: Coherus Biosciences, Inc.
Treatment for: Nasopharyngeal Carcinoma
Toripalimab is an anti-PD-1 monoclonal antibody in development for the treatment of nasopharyngeal carcinoma.
AXS-07 (meloxicam and rizatriptan)
Company: Axsome Therapeutics, Inc.
Treatment for: Migraine
AXS-07 (meloxicam and rizatriptan) is a non-steroidal anti-inflammatory drug and triptan combination in development for the acute treatment of migraine.
Pedmark (sodium thiosulfate)
Company: Fennec Pharmaceuticals Inc.
Treatment for: Prevention of Cisplatin-Induced Ototoxicity
Pedmark (sodium thiosulfate) is a cisplatin neutralizing agent in development for the protection against hearing loss in pediatric patients receiving cisplatin chemotherapy.
- Fennec Pharmaceuticals Announces FDA Acceptance for Filing of New Drug Application Resubmission for Pedmark - April 27, 2022
- Fennec Pharmaceuticals Resubmits New Drug Application to U.S. Food And Drug Administration for Pedmark - March 24, 2022
- Fennec Pharmaceuticals Expects to Receive Complete Response Letter from the FDA for its New Drug Application for Pedmark™ to Prevent Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors - November 29, 2021
- Fennec Pharmaceuticals Announces FDA Acceptance of New Drug Application Resubmission for Pedmark - June 22, 2021
- Fennec Pharmaceuticals Resubmits New Drug Application To U.S. Food And Drug Administration For Pedmark - May 28, 2021
- Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for Pedmark to Prevent Ototoxicity Associated With Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors - August 11, 2020
- Fennec Pharmaceuticals Initiates Rolling New Drug Application to FDA for Pedmark - December 20, 2018
daprodustat
Company: GlaxoSmithKline
Treatment for: Anemia Associated with Chronic Renal Failure
Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in development for the treatment of patients with anemia of chronic kidney disease (CKD).
pegzilarginase
Company: Aeglea BioTherapeutics, Inc.
Treatment for: Arginase 1 Deficiency
Pegzilarginase is a novel, recombinant human arginase 1 enzyme replacement therapy in development for the treatment of Arginase 1 Deficiency (ARG1-D).
vutrisiran
Company: Alnylam Pharmaceuticals, Inc.
Treatment for: Hereditary Transthyretin-Mediated (hATTR) Amyloidosis
Vutrisiran is an investigational RNAi therapeutic in development for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.
- Alnylam Announces 3-Month Extension of Review Period for New Drug Application for Vutrisiran - April 4, 2022
- Alnylam Announces U.S. Food and Drug Administration Acceptance of New Drug Application for Investigational Vutrisiran for the Treatment of the Polyneuropathy of Hereditary ATTR Amyloidosis - June 24, 2021
omaveloxolone
Company: Reata Pharmaceuticals, Inc.
Treatment for: Friedreich’s Ataxia
Omaveloxolone is an investigational, oral, once-daily, activator of Nrf2 (nuclear factor erythroid 2–related factor 2) in development for the treatment of Friedreich’s ataxia.
- Reata Pharmaceuticals Completes Rolling Submission of New Drug Application for Omaveloxolone for the Treatment of Patients with Friedreich’s Ataxia - March 31, 2022
- Reata Pharmaceuticals Initiates Rolling Submission of New Drug Application with U.S. FDA for Omaveloxolone for the Treatment of Patients with Friedreich’s Ataxia - January 31, 2022
Lytenava (bevacizumab-vikg) Intravitreal Injection
Company: Outlook Therapeutics
Lytenava (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab in development for the treatment of wet AMD and other retinal diseases.
futibatinib
Company: Taiho Oncology, Inc.
Treatment for: Cholangiocarcinoma of Biliary Tract
Futibatinib is an investigational, oral, potent, selective, and irreversible tyrosine kinase inhibitor of FGFR1, 2, 3 and 4 being studied as a potential treatment for patients with advanced solid tumors with FGFR1-4 genetic aberrations, including cholangiocarcinoma, who were previously treated with chemotherapy or other therapies.
vadadustat
Company: Akebia Therapeutics, Inc.
Treatment for: Anemia Associated with Chronic Renal Failure
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor in development for the treatment of anemia due to chronic kidney disease (CKD) in adults.
- Akebia Therapeutics Receives Complete Response Letter from the FDA for Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients - March 30, 2022
- Akebia and Otsuka Announce FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis - June 1, 2021
- Akebia Submits New Drug Application (NDA) to the FDA for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis - March 30, 2021
vamorolone
Company: Santhera Pharmaceuticals and ReveraGen BioPharma, Inc.
Treatment for: Duchenne Muscular Dystrophy
Vamorolone is a first-in-class steroidal anti-inflammatory in development for the treatment of Duchenne muscular dystrophy (DMD).
Defencath (taurolidine)
Company: CorMedix Inc.
Treatment for: Prevention of Catheter Related Blood Stream Infections (CRBSI)
Defencath (taurolidine) is a synthetic broad-spectrum antimicrobial and antifungal in development for use as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections (CRBSI).
- Cormedix Inc. Announces FDA Acceptance of Resubmission of New Drug Application for Defencath - March 28, 2022
- CorMedix Inc. Announces FDA Decision That Advisory Committee Meeting for New Drug Application for Defencath is Not Needed - November 18, 2020
- CorMedix Inc. Announces FDA Acceptance for Filing and Priority Review of New Drug Application for Defencath - August 31, 2020
- CorMedix Inc. Reports Submission of Defencath™ New Drug Application - July 8, 2020
sintilimab
Company: Eli Lilly and Company
Treatment for: Non-Small Cell Lung Cancer
Sintilimab is an investigational PD-1 inhibitor in development for the treatment of patients with nonsquamous non-small cell lung cancer (NSCLC).
- Lilly Announces Complete Response Letter for Sintilimab in Combination with Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of People with Nonsquamous Non-Small Cell Lung Cancer - March 24, 2022
- U.S. FDA Accepts Regulatory Submission for Sintilimab in Combination with Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of People with Nonsquamous Non-Small Cell Lung Cancer - May 18, 2021
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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