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.
Luxturna (voretigene neparvovec)
Company: Spark Therapeutics
Treatment for: Biallelic RPE65-Mediated Inherited Retinal Disease
Luxturna (voretigene neparvovec) is an investigational adeno-associated viral (AAV) vector gene therapy for the treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease (IRD).
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.
CL-108 (acetaminophen, hydrocodone and promethazine)
Company: Charleston Laboratories, Inc. and Daiichi Sankyo, Inc.
Treatment for: Pain, Nausea/Vomiting
CL-108 (acetaminophen, hydrocodone and promethazine) is an analgesic and antihistamine fixed-dose combination in development for the relief of moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV).
- Charleston Laboratories, Inc. Resubmits NDA for CL-108 - October 17, 2017
- Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Receive Complete Response Letter from FDA for NDA for CL-108 (hydrocodone, acetaminophen, promethazine) Tablets - February 3, 2017
- Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce FDA Acceptance of New Drug Application (NDA) for CL-108 - June 13, 2016
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Migraine Prophylaxis
Fremanezumab is a fully-humanized monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) ligand in development for the preventive treatment of migraine.
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.
- Aerie Pharmaceuticals Announces FDA Advisory Committee Vote in Favor of Rhopressa (netarsudil ophthalmic solution) 0.02% - October 13, 2017
- Aerie Pharmaceuticals Announces FDA Acceptance of NDA Submission for Rhopressa (netarsudil ophthalmic solution) 0.02% - May 15, 2017
- Aerie Pharmaceuticals Announces Resubmission of NDA for Rhopressa (netarsudil ophthalmic solution) 0.02% - March 1, 2017
- Aerie Pharmaceuticals Submits NDA to U.S. FDA for Rhopressa (netarsudil ophthalmic solution) 0.02% - September 6, 2016
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 Receives Complete Response Letter from the FDA for DSUVIA NDA - October 12, 2017
- AcelRx Pharmaceuticals' New Drug Application for DSUVIA Accepted for Filing - February 27, 2017
- 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
Company: Janssen Biotech, Inc.
Treatment for: Prostate Cancer
Apalutamide is an investigational, next generation oral androgen receptor inhibitor in development for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC).
Company: Rigel Pharmaceuticals, Inc.
Treatment for: Immune Thrombocytopenia
Fostamatinib is an investigational oral spleen tyrosine kinase (SYK) inhibitor in development for the treatment of patients with chronic and persistent immune thrombocytopenia (ITP).
- Rigel Provides Update on FDA Review of Fostamatinib for ITP - October 2, 2017
- FDA Accepts Rigel's New Drug Application for Tavalisse (fostamatinib disodium) for the Treatment of Chronic ITP - June 19, 2017
- Rigel Announces Tavalisse as Proprietary Name for Fostamatinib in the United States - April 27, 2017
- Rigel Submits New Drug Application to FDA for Fostamatinib in Chronic ITP - April 17, 2017
KIT-302 (amlodipine and celecoxib)
Company: Kitov Pharmaceuticals Holdings Ltd.
Treatment for: Hypertension, Osteoarthritis
KIT-302 (amlodipine and celecoxib) is a calcium channel blocker and nonsteroidal anti-inflammatory drug combination in development for the treatment of both hypertension and pain associated with osteoarthritis.
- Kitov Announces Filing by FDA of New Drug Application for KIT-302 - October 2, 2017
- Kitov Submits New Drug Application to FDA for KIT-302 - July 31, 2017
- Kitov Updates on KIT-302 New Drug Application - June 26, 2017
buprenorphine Sublingual Spray
Company: Insys Therapeutics, Inc.
Treatment for: Pain
Buprenorphine Sublingual Spray is a novel sublingual spray formulation of the partial mu-opioid agonist buprenorphine in development for the management of moderate-to-severe acute pain.
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.
- Intellipharmaceutics Receives Complete Response Letter from the FDA for Rexista NDA - September 25, 2017
- Intellipharmaceutics Announces FDA Acceptance for Filing of NDA for Rexista (oxycodone hydrochloride extended release) Abuse Deterrent Opioid Analgesic - February 2, 2017
- Intellipharmaceutics Submits NDA for Rexista (oxycodone hydrochloride extended release), an Abuse Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain - November 25, 2016
Linhaliq (ciprofloxacin liposomal) for Inhalation
Company: Aradigm Corporation
Linhaliq is an inhalation formulation of liposome encapsulated and unencapsulated ciprofloxacin in development for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa.
Company: Janssen Biotech, Inc.
Treatment for: Rheumatoid Arthritis
Plivensia (sirukumab) is a human anti-interleukin-6 monoclonal antibody in development for the treatment of rheumatoid arthritis.
- Janssen Receives Complete Response Letter From U.S. FDA for Sirukumab Biologics License Application - September 22, 2017
- FDA Advisory Committee Does Not Recommend Approval of Sirukumab for the Treatment of Moderately to Severely Active Rheumatoid Arthritis - August 2, 2017
- Janssen Submits Application Seeking Approval of Sirukumab in United States for Rheumatoid Arthritis - September 23, 2016
Company: Amicus Therapeutics
Treatment for: Fabry Disease
Migalastat (AT1001) is an investigational pharmacological chaperone in development for the treatment of Fabry disease.
- FDA Grants Fast Track Designation for Amicus Therapeutics' Migalastat for Treatment of Fabry Disease - September 19, 2017
- FDA Confirms Amicus Therapeutics May Submit New Drug Application for Migalastat for Fabry Disease - July 11, 2017
- Amicus Therapeutics Announces U.S. Regulatory Pathway for Migalastat for Fabry Disease - November 28, 2016
- Amicus Therapeutics Plans to Submit NDA for Migalastat for Fabry Disease Following Positive Pre-NDA Meeting With FDA - September 15, 2015
Company: Camurus and Braeburn Pharmaceuticals
Treatment for: Opiate Dependence
CAM2038 (buprenorphine) is a long-acting partial opioid agonist formulation in development for the treatment of opioid dependence.
Shingrix (herpes zoster subunit vaccine )
Treatment for: Herpes Zoster -- Prophylaxis
Shingrix (herpes zoster subunit vaccine) is a non-live, recombinant subunit vaccine in development to help prevent herpes zoster (shingles).
ZTlido (lidocaine) Patch - formerly Ztilido
Company: Scilex Pharmaceuticals, Inc.
Treatment for: Postherpetic Neuralgia
ZTlido (lidocaine patch 1.8%) is a transdermal anesthetic formulation in development for the treatment of postherpetic neuralgia.
- FDA Acknowledges Receipt of Sorrento Therapeutics Inc, NDA for ZTlido - September 12, 2017
- Sorrento Therapeutics, Inc. Submits NDA For ZTlido Next-Generation Lidocaine Patch - August 29, 2017
- FDA Accepts Scilex Pharmaceuticals' NDA Filing for ZTlido - September 16, 2015
- Scilex Pharmaceuticals Initiates Pivotal Pharmacokinetic Study for Ztilido - May 15, 2014
- Scilex Pharmaceuticals Announces Filing of Investigational New Drug Application for Ztilido - March 24, 2014
Company: AbbVie, Inc.
Treatment for: Endometriosis
Elagolix is an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist in development for the management of endometriosis with associated pain.
Admelog (insulin lispro) Injection
Treatment for: Diabetes Type 1, Diabetes Type 2
Admelog (insulin lispro) is a follow-on insulin product (referenced to Humalog) in development for the treatment of patients with type 1 and type 2 diabetes.
Company: Akcea Therapeutics, Inc.
Treatment for: Familial Chylomicronemia Syndrome
Volanesorsen is an antisense oligonucleotide apolipoprotein C-III (ApoC-III) inhibitor in development for the treatment of familial chylomicronemia syndrome (FCS).