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: Shire plc
Treatment for: Attention-Deficit/Hyperactivity Disorder (ADHD)
SHP465 is a long-acting, triple-bead, mixed amphetamine salts formulation in development as a potential once-daily treatment for Attention-Deficit/Hyperactivity Disorder (ADHD).
Solosec (secnidazole) Oral Granules
Company: Symbiomix Therapeutics
Treatment for: Bacterial Vaginosis
Solosec (secnidazole) is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties anticipated to be the first and only single-dose oral therapy approved for the treatment of bacterial vaginosis (BV).
Company: Ezra Innovations, LLC
Treatment for: Hypertension, Congestive Heart Failure
EZR-104 (valsartan) is a novel formulation of the angiotensin receptor blocker valsartan, with patented RubiretenTM delivery technology, in development for the treatment of hypertension and heart failure.
Cinvanti (aprepitant) Injection
Company: Heron Therapeutics, Inc.
Treatment for: Nausea/Vomiting -- Chemotherapy Induced
Cinvanti (aprepitant) is a polysorbate 80 free, intravenous formulation of aprepitant, an NK1 receptor antagonist indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV).
Company: Eli Lilly and Company and Incyte Corporation
Treatment for: Rheumatoid Arthritis
Baricitinib is an oral selective JAK1 and JAK2 inhibitor in development for the treatment of rheumatoid arthritis.
Company: Mylan N.V. and Biocon Ltd.
Treatment for: Breast Cancer
MYL-1401O is a proposed biosimilar to branded trastuzumab (Herceptin), indicated for the treatment of certain HER2-positive breast cancers.
Company: Alcobra Ltd.
Treatment for: Attention Deficit Disorder
Metadoxine is an ion-pair salt of pyridoxine (vitamin B6) in development for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).
DSUVIA (sufentanil) Sublingual Tablets - formerly ARX-04
Company: AcelRx Pharmaceuticals, Inc.
Treatment for: Pain
DSUVIA (sufentanil) is a synthetic opioid analgesic administered sublingually by a healthcare professional for the treatment of patients experiencing moderate-to-severe acute pain in a medically supervised setting.
- AcelRx Pharmaceuticals Provides Guidance on 2017 Milestones for ARX-04, now known as DSUVIA in the United States, for the Treatment of Moderate-to-Severe Acute Pain - January 8, 2017
- AcelRx Pharmaceuticals Submits New Drug Application for ARX-04 for the Treatment of Moderate-To-Severe Acute Pain - December 13, 2016
ADS-5102 (amantadine hydrochloride) Extended-Release Capsules
Company: Adamas Pharmaceuticals, Inc.
Treatment for: Parkinson's Disease
ADS-5102 (amantadine hydrochloride) is a chrono-synchronous amantadine therapy for the potential treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease.
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 Provides Update on FDA Advisory Committee for Ingrezza (valbenazine) for the Treatment of Tardive Dyskinesia - January 5, 2017
- 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
Duzallo (allopurinol and lesinurad)
Company: Ironwood Pharmaceuticals, Inc.
Duzallo (allopurinol and lesinurad) is a xanthine oxidase inhibitor and URAT1 inhibitor fixed-dose combination in development for the treatment of hyperuricemia in patients with uncontrolled gout.
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).
- Cempra Receives Complete Response Letter From FDA For Solithromycin NDAs - December 29, 2016
- 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: Portola Pharmaceuticals Inc.
Treatment for: Venous Thromboembolism
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.
- Portola Pharmaceuticals Announces FDA Accepts NDA for Priority Review for Oral, Factor Xa Inhibitor Anticoagulant Betrixaban - December 23, 2016
- Portola Pharmaceuticals Submits NDA to U.S. FDA for Betrixaban for Extended Duration Prophylaxis of Venous Thromboembolism in Acute Medically Ill Patients - October 25, 2016
SequestOx (naltrexone and oxycodone hydrochloride)
Company: Elite Pharmaceuticals, Inc.
Treatment for: Pain
SequestOx (oxycodone hydrochloride and naltrexone) is an abuse-deterrent opioid formulation in development for the management of moderate to severe pain.
- Elite Provides Update On SequestOx New Drug Application - December 22, 2016
- FDA Issues Complete Response Letter For SequestOx New Drug Application - July 15, 2016
- Elite Announces U.S. FDA Priority Review Designation for SequestOx NDA - March 17, 2016
Lutathera (lutetium Lu 177 dotatate)
Company: Advanced Accelerator Applications S.A.
Treatment for: Neuroendocrine Carcinoma
Lutathera (lutetium Lu 177 dotatate) is a Lu-177-labeled somatostatin analogue peptide in development for the treatment of gastroenteropancreatic neuroendocrine tumors.
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.
- Tesaro Announces Priority Review Designation for Niraparib NDA - December 20, 2016
- Tesaro Announces Submission of Niraparib NDA For Platinum-sensitive, Recurrent Ovarian Cancer - November 1, 2016
- Tesaro Receives FDA Fast Track Designation for Niraparib and Initiates Rolling NDA Submission - September 12, 2016
Cotempla XR-ODT (methylphenidate) Extended-Release Orally Disintegrating Tablets
Company: Neos Therapeutics, Inc.
Treatment for: Attention-Deficit/Hyperactivity Disorder (ADHD)
Cotempla XR-ODT (methylphenidate) is a once-daily, extended-release, orally disintegrating tablet formulation of the stimulant methylphenidate, in development for the treatment of attention-deficit/hyperactivity disorder (ADHD).
- Neos Therapeutics Completes Resubmission of NDA for Cotempla XR-ODT for the Treatment of ADHD - December 20, 2016
- Neos Therapeutics Receives Complete Response Letter From the FDA for Cotempla XR-ODT - November 10, 2015
- Neos Therapeutics Announces Submission of NDA for its Methylphenidate Extended Release Oral Disintegrating Tablet (XR-ODT) for the Treatment of ADHD - January 12, 2015
Company: Genentech, Inc.
Treatment for: Multiple Sclerosis
Ocrevus (ocrelizumab) is a humanized monoclonal antibody designed to target CD20-positive B-cells, which are implicated in the inflammatory and neurodegenerative processes of multiple sclerosis. Ocrevus is an investigational treatment for both relapsing (RMS) and primary progressive (PPMS) forms of multiple sclerosis.
Company: AbbVie Inc.
Treatment for: Chronic Hepatitis C
Glecaprevir/pibrentasvir (G/P) is a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, in development for the treatment of all major genotypes (GT1-6) of chronic hepatitis C.