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.
Company: Novo Nordisk
Treatment for: Diabetes Type 2
Semaglutide is a once-weekly glucagon-like peptide-1 (GLP-1) analog in development for the treatment of adults with type 2 diabetes.
Company: Neurocrine Biosciences, Inc.
Treatment for: Tardive Dyskinesia
Ingrezza (valbenazine) is a novel, highly-selective VMAT2 inhibitor in development for the treatment of tardive dyskinesia.
- Neurocrine Announces FDA Advisory Committee Meeting to Review Ingrezza (valbenazine) NDA for the Treatment of Tardive Dyskinesia - November 29, 2016
- Neurocrine Announces Ingrezza (valbenazine) NDA for the Treatment of Tardive Dyskinesia has been Accepted for Priority Review by FDA - October 11, 2016
- Neurocrine Announces FDA Conditional Acceptance of Proprietary Name Ingrezza for VMAT2 Inhibitor Valbenazine - August 31, 2016
- Neurocrine Submits New Drug Application for Valbenazine for Treatment of Tardive Dyskinesia - August 29, 2016
Company: EMD Serono Inc.
Treatment for: Merkel Cell Carcinoma
Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody in development for the treatment of metastatic Merkel cell carcinoma.
Company: Amicus Therapeutics
Treatment for: Fabry Disease
Migalastat (AT1001) is an investigational pharmacological chaperone in development for the treatment of Fabry disease.
Rexista (oxycodone hydrochloride) Extended-Release Tablets
Company: Intellipharmaceutics International Inc.
Treatment for: Pain
Rexista (oxycodone hydrochloride extended release) is an abuse and alcohol-deterrent controlled-release formulation of oxycodone hydrochloride in development for the relief of moderate to severe pain.
Treatment for: Chronic Obstructive Pulmonary Disease
FF/UMEC/VI (fluticasone furoate/umeclidinium/vilanterol) is an investigational once-daily ‘closed’ triple combination therapy comprising an inhaled corticosteroid, a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA), in development for the treatment of patients with chronic obstructive pulmonary disease (COPD).
Vitaros (alprostadil) Cream - formerly Alprox-TD
Company: Apricus Biosciences, Inc.
Treatment for: Erectile Dysfunction
Vitaros (alprostadil) is a topical vasodilator cream in development for the treatment of erectile dysfunction.
- Apricus Biosciences Provides Update on Vitaros NDA Following Receipt of FDA Feedback - November 18, 2016
- NexMed Discusses End of Review Meeting for Vitaros - October 20, 2008
- NexMed Receives FDA Response for Topical ED Product - July 23, 2008
- NexMed Confirms FDA Acceptance of NDA for Erectle Dysfunction Product - November 20, 2007
- NexMed Files NDA for Proprietary Erectile Dysfunction Treatment - September 24, 2007
NT-0201 (amphetamine) Extended-Release Liquid Suspension
Company: Neos Therapeutics, Inc.
Treatment for: Attention-Deficit Hyperactivity Disorder (ADHD)
NT-0201 (amphetamine) is an extended-release liquid suspension amphetamine formulation in development for the treatment of ADHD.
ABP 215 (bevacizumab)
Company: Amgen Inc.
Treatment for: Non-Small Cell Lung Cancer, Colorectal Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Breast Cancer, Ovarian Cancer
ABP 215 (bevacizumab) is an anti-vascular endothelial growth factor A (anti-VEGF) monoclonal antibody biosimilar to Avastin (bevacizumab) in development for the treatment of non-squamous non-small cell lung cancer (NSCLC) and other cancers.
- Amgen and Allergan Submit Biosimilar BLA for ABP 215 to U.S. FDA - November 15, 2016
Heplisav-B (hepatitis b adult vaccine)
Company: Dynavax Technologies Corporation
Treatment for: Hepatitis B Prophylaxis
Heplisav-B (hepatitis b adult vaccine) is an investigational vaccine intended for use in the immunization against infection caused by all known subtypes of hepatitis B virus.
- Dynavax Receives Complete Response Letter from U.S. FDA for Biologics License Application for Heplisav-B - November 14, 2016
- Dynavax Provides Regulatory Update on Heplisav-B - October 4, 2016
- Dynavax Reports Feedback From FDA Meeting Regarding Heplisav Biologic License Application - June 10, 2013
- Dynavax Receives FDA Complete Response Letter on Heplisav Biologic License Application - February 25, 2013
- Dynavax Announces FDA Advisory Committee Meeting Outcome for Heplisav - November 16, 2012
- Dynavax Announces FDA Advisory Committee to Review Heplisav - August 29, 2012
- Dynavax Announces FDA Acceptance of Heplisav BLA - June 27, 2012
- Dynavax Reports Heplisav BLA Submission - April 27, 2012
Company: Cempra, Inc.
Treatment for: Community Acquired Bacterial Pneumonia
Solithera (solithromycin) is a next-generation oral and intravenous fluoroketolide in clinical development for the treatment of moderate to moderately-severe community acquired bacterial pneumonia (CABP).
- FDA Advisory Committee Votes That Efficacy Results of Cempra's Solithromycin Outweigh Risks for Community-Acquired Bacterial Pneumonia - November 4, 2016
- Cempra Announces FDA Acceptance of Solithera New Drug Applications in the Treatment of Community-Acquired Bacterial Pneumonia - July 5, 2016
- Cempra Completes NDA Submissions for Solithromycin in the Treatment of Community-Acquired Bacterial Pneumonia - May 1, 2016
- FDA Grants Fast Track Designation to Cempra for Solithromycin in the Treatment of Community Acquired Bacterial Pneumonia - August 19, 2015
Company: Tesaro, Inc.
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Niraparib is an oral, poly ADP-ribose polymerase (PARP) inhibitor in development for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.
Company: Ariad Pharmaceuticals, Inc.
Treatment for: Non-Small Cell Lung Cancer
Brigatinib is an investigational anaplastic lymphoma kinase (ALK) inhibitor in development for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease is resistant to crizotinib.
- ARIAD Announces U.S. Food and Drug Administration Acceptance of NDA Filing for Brigatinib - October 31, 2016
- ARIAD Completes Rolling Submission of NDA for Brigatinib to the U.S. FDA - August 30, 2016
- ARIAD Initiates Submission of New Drug Application for Brigatinib to the U.S. FDA Ahead of Plan - June 17, 2016
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Rheumatoid Arthritis
Sarilumab is an investigational interleukin-6 receptor (IL-6R) antibody in development for the treatment of patients with rheumatoid arthritis.
Treatment for: Spinal Muscular Atrophy
Spinraza (nusinersen) is an antisense oligonucleotide in development for the treatment of spinal muscular atrophy.
Macrilen (macimorelin acetate)
Company: Aeterna Zentaris Inc.
Treatment for: Adult Human Growth Hormone Deficiency
Macrilen (macimorelin) is a ghrelin agonist in development for use in evaluating adult growth hormone deficiency (AGHD).
- Aeterna Zentaris Completes Patient Recruitment for Confirmatory Phase 3 Trial of Macrilen - October 26, 2016
- Aeterna Zentaris Announces Plans to Initiate Phase 3 Study of Macrilen in AGHD - April 13, 2015
- FDA Issues Complete Response Letter for Macrilen (macimorelin) NDA in Adult Growth Hormone Deficiency - November 6, 2014
- Aeterna Zentaris NDA for Macimorelin Acetate in AGHD Accepted for Filing by the FDA - January 6, 2014
- Aeterna Zentaris Submits New Drug Application to FDA for Macimorelin Acetate (AEZS-130) for Evaluation of AGHD - November 5, 2013
Company: Portola Pharmaceuticals Inc.
Betrixaban is an oral, once-daily Factor Xa inhibitor anticoagulant in development for the extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
Company: Melinta Therapeutics
Treatment for: Gonococcal Infection -- Uncomplicated, Skin and Structure Infection
Baxdela (delafloxacin) is a novel investigational fluoroquinolone in development for the treatment of uncomplicated gonorrhea, and acute bacterial skin and skin structure infections.
Company: Newron Pharmaceuticals S.p.A.
Treatment for: Parkinson's Disease
Xadago (safinamide) is an alpha-aminoamide in development as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson’s disease.
- US FDA Considers Newron’s Re-Submitted NDA for Xadago to be a Complete, Class 2 Response to Complete Response Letter - October 21, 2016
- Newron Re-Submits US NDA for Xadago (safinamide) - September 22, 2016
- Newron to Re-Submit US NDA for Xadago (safinamide) - July 26, 2016
- Newron Receives Complete Response Letter from US FDA for Xadago (safinamide) - March 29, 2016
- Xadago (safinamide) NDA Late-Cycle Review Meeting Completed with U.S. FDA - September 30, 2015
- Xadago (safinamide) NDA Accepted for Filing by the U.S. FDA - March 2, 2015
- Safinamide NDA Re-submitted to the U.S. FDA - December 29, 2014
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Huntington Disease, Tardive Dyskinesia
SD-809 (deutetrabenazine) is an investigational vesicular monoamine 2 transporter (VMAT2) inhibitor intended for the treatment of chorea associated with Huntington disease.
- Teva Announces FDA Acceptance of Resubmitted NDA for SD-809 for Treatment of Chorea Associated with Huntington Disease - October 20, 2016
- Teva Receives Complete Response Letter for NDA for SD-809 for the Treatment of Chorea Associated with Huntington Disease - May 31, 2016
- Teva Announces Breakthrough Therapy Designation for SD-809 Granted by FDA for the Treatment of Tardive Dyskinesia - November 9, 2015
- Teva Announces FDA Acceptance of NDA for SD-809 for Treatment in Huntington Disease - August 12, 2015