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.
Midomafetamine
Company: Lykos Therapeutics
Treatment for: Post Traumatic Stress Disorder
Midomafetamine (commonly referred to as MDMA or ecstasy) is an empathogen (entactogen) psychoactive in development for the treatment of post-traumatic stress disorder in combination with psychological intervention, including psychotherapy.
- Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD - August 9, 2024
- Lykos Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSD - February 9, 2024
- MAPS PBC Announces Submission of New Drug Application to the FDA for MDMA-Assisted Therapy for PTSD - December 12, 2023
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).
- FDA Advisory Committee Votes Favorably that the Data Support Arimoclomol as Effective Treatment for Patients with Niemann-Pick Disease Type C - August 2, 2024
- 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
VX-548 (suzetrigine) oral tablet
Treatment for: Neuropathic Pain, Pain, Postoperative Pain
VX-548 (suzetrigine) is an experimental analgesic that is currently undergoing investigational trials to assess its ability to relieve moderate to severe acute pain or peripheral neuropathic pain. VX-548 works by selectively blocking an ion channel (Nav1.8).
Dasynoc (dasatinib) - formerly XS004
Company: Xspray Pharma AB
Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia
Dasynoc (dasatinib) is an optimized version of the approved kinase inhibitor dasatinib in development for the treatment of chronic myeloid leukemia and acute lymphoblastic leukemia.
- Xspray Pharma Shares New Information on Dasynoc, a Novel CML Treatment in Development - July 26, 2024
- FDA Accepts Xspray Pharma’s NDA-Resubmission for Dasynoc - February 12, 2024
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(R)) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease - July 17, 2024
- Atara Biotherapeutics Submits Tabelecleucel (Tab-cel(R)) 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
Zynquista (sotagliflozin)
Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Diabetes, Type 1
Zynquista (sotagliflozin) is a dual sodium-glucose co-transporter-1 and -2 inhibitor in development as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD).
- Lexicon Pharmaceuticals Receives December 20, 2024 PDUFA Goal Date for Sotagliflozin Type 1 Diabetes NDA Resubmission - July 16, 2024
- Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 Diabetes - June 21, 2024
- Lexicon Voluntarily Withdraws Sotagliflozin New Drug Application and Plans Prompt Resubmission Targeted Early Q2 2022 - February 28, 2022
- FDA Issues Complete Response Letter for Zynquista (sotagliflozin) - March 25, 2019
- FDA Advisory Committee Votes on Zynquista (sotagliflozin) as Treatment for Adults with Type 1 Diabetes - January 17, 2019
- FDA to Review Zynquista (sotagliflozin) as Potential Treatment for Type 1 Diabetes - May 22, 2018
- Lexicon Pharmaceuticals Announces Regulatory Submissions for Sotagliflozin to Treat Adults with Type 1 Diabetes - March 26, 2018
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
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.
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
Yorvipath (palopegteriparatide) Injection - formerly TransCon PTH
Company: Ascendis Pharma, Inc.
Treatment for: Hypoparathyroidism
Yorvipath (palopegteriparatide) is a parathyroid hormone analog (PTH(1-34)) indicated for the treatment of hypoparathyroidism in adults.
- FDA Approves Yorvipath (palopegteriparatide) for the Treatment of Hypoparathyroidism in Adults - August 12, 2024
- Ascendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon PTH for Adults with Hypoparathyroidism - May 14, 2024
- FDA Accepts for Review Resubmitted NDA for TransCon PTH (palopegteriparatide) in Adult Patients with Hypoparathyroidism - December 11, 2023
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
See also: Generic approvals, New drug approvals, Recent additions to drugclasses.com, Alphabetical listing of all new drug applications, FDA approval process
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