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.
Zalviso (sufentanil) Sublingual Microtablet System
Company: AcelRx Pharmaceuticals, Inc.
Treatment for: Pain
Zalviso (sufentanil sublingual microtablet system) is a patient-activated, non-invasive analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting.
- AcelRx Pharmaceuticals Receives Complete Response Letter from FDA for NDA for Zalviso - July 25, 2014
- Zalviso New Drug Application Accepted for Filing by FDA - December 2, 2013
- AcelRx Pharmaceuticals Submits New Drug Application to the FDA for Zalviso - September 30, 2013
naloxone Nasal Spray
Treatment for: Opioid Overdose
Naloxone Nasal Spray is an opioid antagonist intranasal formulation in development for the treatment of opioid overdose.
Company: Medicines360 and Actavis plc
Treatment for: Contraception
Levosert (levonorgestrel) is a hormonal intrauterine contraceptive (IUC) for use by women to prevent pregnancy.
Company: InterMune, Inc.
Treatment for: Idiopathic Pulmonary Fibrosis
Esbriet (pirfenidone) is an orally active small molecule drug that may inhibit collagen synthesis, down regulate production of multiple cytokines and block fibroblast proliferation and stimulation in response to cytokines. Pirfenidone is in development for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
- InterMune Receives FDA Breakthrough Therapy Designation for Pirfenidone, an Investigational Treatment for IPF - July 17, 2014
- InterMune Announces Resubmission Of NDA For Pirfenidone For The Treatment Of Patients With IPF - May 27, 2014
- InterMune Announces Expanded Access Program for Pirfenidone to Treat Idiopathic Pulmonary Fibrosis (IPF) in the United States - May 16, 2014
- InterMune Reports Phase 3 ASCEND Trial Results of Pirfenidone in Idiopathic Pulmonary Fibrosis (IPF) - February 25, 2014
- Coalition for Pulmonary Fibrosis Responds to News of Further Review of Pirfenidone By FDA - May 7, 2010
- InterMune Receives FDA Complete Response Letter on Esbriet (pirfenidone) New Drug Application - May 5, 2010
- FDA Advisory Committee Recommends Approval of InterMune's Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis - March 10, 2010
- InterMune Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Pirfenidone - March 5, 2010
- FDA Grants Priority Review of Pirfenidone NDA for the Treatment of Patients With IPF - January 6, 2010
- InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF - November 4, 2009
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Idiopathic Pulmonary Fibrosis
Nintedanib is an investigational small molecule tyrosine kinase inhibitor (TKI) in development for the treatment of idiopathic pulmonary fibrosis.
Treatment for: Aspergillosis -- Invasive
Isavuconazole is a broad-spectrum antifungal in development for the treatment of invasive aspergillosis and invasive mucormycosis.
Toujeo (insulin glargine [rDNA origin])
Treatment for: Diabetes Type 1, Diabetes Type 2
Toujeo (insulin glargine [rDNA origin] is an investigational basal insulin in development for the treatment of diabetes.
Treatment for: Ovarian Cancer
Olaparib is an investigational, potential first-in-class oral poly ADP ribose polymerase (PARP) inhibitor in development for the treatment of ovarian cancer.
Treatment for: HIV Infection
Lamivudine and raltegravir is a fixed-dose combination of a nucleoside analog reverse transcriptase inhibitor and an integrase strand transfer inhibitor in development for the treatment of HIV-1 infection.
Company: Boehringer Ingelheim and Eli Lilly and Company
Treatment for: Diabetes Type 2
Empagliflozin is an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor in development for the treatment of type 2 diabetes.
Treatment for: Diabetes Type 2
Lyxumia (lixisenatide) is a once-daily prandial GLP-1 receptor agonist in development for the treatment of adults with type 2 diabetes mellitus.
- Sanofi's Lyxumia (lixisenatide) Showed More Pronounced After-Test-Meal Blood Sugar Lowering than Liraglutide when Both were Added to Insulin Glargine - June 14, 2014
- Sanofi Provides Update on Lixisenatide New Drug Application in U.S. - September 12, 2013
- Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA - February 19, 2013
Treatment for: Opioid-Induced Constipation
Movantik (naloxegol) is a peripherally-acting mu-opioid receptor antagonist being investigated for the treatment of constipation as a side effect of prescription opioid pain medicines.
- FDA Advisory Committee to Discuss Peripherally-Acting Opioid Receptor Antagonists - June 11, 2014
- New Drug Application for Naloxegol Accepted by United States Food and Drug Administration - November 19, 2013
- AstraZeneca Announces Results From Long-Term Safety Trial Of Naloxegol In Patients With Opioid-Induced Constipation - February 26, 2013
TNX-102 (cyclobenzaprine hydrochloride)
Company: Tonix Pharmaceuticals Holding Corp.
Treatment for: Post Traumatic Stress Disorder
TNX-102 (cyclobenzaprine) is a sublingual formulation of an approved skeletal muscle relaxant in development for the treatment of patients with post-traumatic stress disorder (PTSD).
Sivextro (tedizolid phosphate) Tablets and Injection
Company: Cubist Pharmaceuticals, Inc.
Treatment for: Skin and Structure Infection
Sivextro (tedizolid phosphate) is an oxazolidinone antibiotic drug indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
- FDA Approves Sivextro (tedizolid phosphate) to Treat Skin Infections - June 20, 2014
- Cubist Announces Publication of Pivotal Data from Sivextro (tedizolid phosphate) ESTABLISH-2 Trial - June 6, 2014
- FDA Advisory Committee Unanimously Recommends Approval of Sivextro (tedizolid phosphate) - March 31, 2014
- Cubist Announces FDA Acceptance of Tedizolid New Drug Application with Priority Review - December 30, 2013
- Cubist Announces Submission of New Drug Application for Investigational Antibiotic Tedizolid for Treatment of Serious Skin Infections - October 23, 2013
Company: Prosensa Holding N.V.
Treatment for: Duchenne Muscular Dystrophy
Drisapersen is an investigational antisense oligonucleotide in development for the treatment of Duchenne Muscular Dystrophy.
Triferic (ferric pyrophosphate citrate)
Company: Rockwell Medical, Inc.
Treatment for: Anemia Associated with Chronic Renal Failure
Triferic (ferric pyrophosphate citrate) is an investigational iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis.
- Rockwell Medical Announces FDA Acceptance for Filing of Triferic New Drug Application - May 28, 2014
- Rockwell Medical Submits NDA for Triferic - March 24, 2014
Zerenex (ferric citrate coordination complex)
Company: Keryx Biopharmaceuticals, Inc.
Treatment for: Hyperphosphatemia of Renal Failure
Zerenex (ferric citrate coordination complex) is a ferric iron-based phosphate binder in development for the treatment of hyperphosphatemia in patients with chronic kidney disease.
- Keryx Receives Notification of PDUFA Date Extension for Zerenex - May 22, 2014
- Keryx Biopharmaceuticals Announces FDA Acceptance for Filing of Zerenex New Drug Application - October 8, 2013
- Keryx Biopharmaceuticals Announces New Drug Application Submission for Zerenex for the Treatment of Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis - August 8, 2013