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.
ZS-9 (sodium zirconium cyclosilicate)
Treatment for: Hyperkalemia
ZS-9 (sodium zirconium cyclosilicate) is a crystalline lattice potassium ion-trap in development for the treatment of hyperkalemia.
- FDA Accepts for Review New Drug Application for Sodium Zirconium Cyclosilicate (ZS-9) for the Treatment of Hyperkalemia - October 18, 2016
- AstraZeneca Receives Complete Response Letter from FDA for Sodium Zirconium Cyclosilicate (ZS-9) for Hyperkalemia - May 27, 2016
- ZS Pharma Announces FDA Acceptance of ZS-9 New Drug Application - July 29, 2015
- ZS Pharma Submits NDA for ZS-9 for the Treatment of Hyperkalemia - May 26, 2015
Arymo ER (morphine sulfate) Extended-Release Tablets
Company: Egalet Corporation
Treatment for: Pain
Arymo ER (morphine sulfate) is an extended-release, abuse-deterrent, opioid analgesic formulation in development for the management of severe pain.
- Egalet Notified that FDA Will Not Meet PDUFA Goal Date for Arymo ER - October 13, 2016
- Egalet Announces FDA Advisory Committees Recommend Approval of Abuse-Deterrent Arymo ER (Morphine Sulfate) - August 4, 2016
- Egalet Announces FDA Acceptance of New Drug Application for Arymo ER (Morphine Sulfate) Extended-Release Tablets - February 29, 2016
- Egalet Submits NDA for Arymo ER (Morphine Sulfate) Extended-Release Tablets - December 15, 2015
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 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: Nicox S.A.
Treatment for: Allergic Conjunctivitis
AC-170 (cetirizine) is a second generation antihistamine topical ophthalmic formulation in development for the treatment of ocular itching associated with allergic conjunctivitis.
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 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
Vyxeos (cytarabine and daunorubicin liposome) Injection
Company: Jazz Pharmaceuticals plc
Treatment for: Acute Myeloid Leukemia
Vyxeos (cytarabine and daunorubicin liposome injection) is an investigational nano-scale liposome co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio in development for the treatment of acute myeloid leukemia.
Company: Pain Therapeutics, Inc.
Treatment for: Pain
Remoxy ER (oxycodone) is a long-acting abuse-resistant narcotic analgesic formulation in development for the treatment of moderate to severe chronic pain.
- Pain Therapeutics Receives Complete Response Letter for Remoxy ER - September 26, 2016
- FDA Accepts Remoxy NDA for Review - April 12, 2016
- Pain Therapeutics Resubmits Remoxy New Drug Application to the U.S. Food and Drug Administration - March 29, 2016
- Pfizer to Discontinue Agreement on Remoxy (oxycodone) Extended-Release Capsules CII - October 27, 2014
- FDA Complete Response Letter Received for Remoxy - June 24, 2011
- Remoxy New Drug Application Accepted by the FDA with PDUFA Goal Date of June 23, 2011 - January 27, 2011
- King Pharmaceuticals and Pain Therapeutics Announce Resubmission of New Drug Application for Remoxy - December 27, 2010
- Pain Therapeutics Receives Complete Response Letter From FDA for Remoxy - December 11, 2008
- Pain Therapeutics and King Pharmaceuticals Announce Submission of New Drug Application for Remoxy - June 10, 2008
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Atopic Dermatitis
Dupixent (dupilumab) is an investigational human monoclonal antibody in development for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis. Dupilumab inhibits signaling of IL-4 and IL-13, two key cytokines required for the type 2 (including Th2) immune response, which is believed to be major driver in the pathogenesis of the disease.
Company: Amgen Inc.
Treatment for: Osteoporosis
Romosozumab is an anti-sclerostin monoclonal antibody in development for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Treatment for: Spinal Muscular Atrophy
Nusinersen is an antisense oligonucleotide in development for the treatment of spinal muscular atrophy.
Company: Janssen Biotech, Inc.
Sirukumab is a human anti-interleukin-6 monoclonal antibody in development for the treatment of rheumatoid arthritis.
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.
- 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: Puma Biotechnology, Inc.
Treatment for: Breast Cancer -- Adjuvant
Neratinib is a potent irreversible tyrosine kinase inhibitor in development for the extended adjuvant treatment of HER2-positive early stage breast cancer.
- Puma Biotechnology Announces FDA Acceptance of NDA for PB272 (Neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer - September 20, 2016
- Puma Biotechnology Submits New Drug Application for PB272 (Neratinib) to FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer - July 21, 2016
Yuvvexy (estradiol) - formerly TX-004HR
Treatment for: Dyspareunia
Yuvvexy (estradiol) is a topical estrogen in an applicator-free, vaginal, softgel capsule formulation for the treatment of dyspareunia (vaginal pain during sexual intercourse) due to menopause.
Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Carcinoid Syndrome
Telotristat etiprate is an oral tryptophan hydroxylase inhibitor in development for the treatment of carcinoid syndrome.
- FDA Extends PDUFA Date for Telotristat Etiprate for the Treatment of Carcinoid Syndrome - September 14, 2016
- Lexicon Announces FDA Priority Review of NDA for Telotristat Etiprate for the Treatment of Carcinoid Syndrome - May 31, 2016
- Lexicon Submits New Drug Application to FDA for Telotristat Etiprate for the Treatment of Carcinoid Syndrome - March 30, 2016
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.
Rhopressa (netarsudil) Ophthalmic Solution
Company: Aerie Pharmaceuticals, Inc.
Treatment for: Glaucoma
Rhopressa (netarsudil ophthalmic solution) is a combination Rho Kinase and norepinephrine transporter (ROCK/NET) inhibitor in development for the treatment of glaucoma or ocular hypertension.
IDegLira (insulin degludec and liraglutide) Injection
Company: Novo Nordisk
Treatment for: Diabetes Type 2
IDegLira (insulin degludec and liraglutide) is a once-daily, single injection fixed combination of the basal insulin analogue insulin degludec (Tresiba), and the GLP-1 analogue liraglutide (Victoza), in development for the treatment of adults with type 2 diabetes.
Company: Array BioPharma
Treatment for: NRAS-Mutant Melanoma
Binimetinib is a late-stage small molecule MEK inhibitor in development for the treatment of advanced NRAS-mutant melanoma.
KedRAB (rabies immunoglobulin human)
Company: Kamada Ltd. and Kedrion S.p.A.
Treatment for: Rabies
KedRAB (human rabies immunoglobulin) is a human plasma derived anti-rabies immunoglobulin in development for the post-exposure treatment of rabies.