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.

Korsuva (difelikefalin)

Company: Cara Therapeutics, Inc.
Treatment for: Chronic Kidney Disease-Associated Pruritus

Korsuva (difelikefalin) is a selective peripheral kappa opioid receptor agonist in development for the treatment of moderate-to-severe pruritus in hemodialysis patients.

gefapixant

Company: Merck
Treatment for: Cough

Gefapixant is an investigational, orally administered, selective P2X3 receptor antagonist, for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.

U.S. FDA Accepts Merck’s Gefapixant New Drug Application for Review - March 1, 2021

bardoxolone

Company: Reata Pharmaceuticals, Inc.
Treatment for: Alport Syndrome

Bardoxolone is an investigational, once-daily, orally administered activator of Nrf2 in development for the treatment of Alport syndrome and autosomal dominant polycystic kidney disease (ADPKD).

Reata Pharmaceuticals, Inc. Submits NDA for Company’s Lead Program: Bardoxolone in Alport Syndrome - March 1, 2021

FT218 (sodium oxybate)

Company: Avadel Pharmaceuticals plc
Treatment for: Narcolepsy

FT218 (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.

Avadel Pharmaceuticals Announces FDA Acceptance of New Drug Application for FT218 in Adults with Narcolepsy for the Treatment of Excessive Daytime Sleepiness and Cataplexy - March 1, 2021

AGN-190584 (pilocarpine) Ophthalmic Solution

Company: Allergan
Treatment for: Presbyopia

AGN-190584 (pilocarpine 1.25%) is an optimized ophthalmic solution formulation of the approved cholinergic muscarinic receptor agonist pilocarpine in development for the treatment of presbyopia.

Allergan Submits New Drug Application for Investigational AGN-190584 for the Treatment of Presbyopia - February 25, 2021

ruxolitinib Cream

Company: Incyte Dermatology
Treatment for: Atopic Dermatitis, Vitiligo

Ruxolitinib is a JAK1/JAK2 inhibitor formulated for topical application in development for the treatment of atopic dermatitis and vitiligo.

Incyte Announces Acceptance and Priority Review of NDA for Ruxolitinib Cream for Atopic Dermatitis - February 19, 2021

tisotumab vedotin

Company: Genmab A/S and Seagen Inc.
Treatment for: Cervical Cancer

Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) in development for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer - February 10, 2021

SPN-812 (viloxazine hydrochloride)

Company: Supernus Pharmaceuticals, Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

SPN-812 (viloxazine hydrochloride) is a serotonin norepinephrine modulating agent (SNMA) in development as a novel, non-stimulant treatment for attention deficit hyperactivity disorder (ADHD).

Supernus Resubmits New Drug Application for SPN-812 for the Treatment of ADHD in Pediatric Patients - February 8, 2021
Supernus Provides Regulatory Update for SPN-812 - November 9, 2020
Supernus Announces FDA Acceptance for Review of New Drug Application for SPN-812 (viloxazine hydrochloride) for the Treatment of ADHD - January 22, 2020
Supernus Submits New Drug Application for SPN-812 for the Treatment of ADHD - November 11, 2019

maralixibat

Company: Mirum Pharmaceuticals, Inc.
Treatment for: Cholestatic Pruritus in Patients with Alagille Syndrome

Maralixibat is an inhibitor of the apical sodium dependent bile acid transporter (ASBT) in development for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).

aducanumab

Company: Biogen
Treatment for: Alzheimer's Disease

Aducanumab (BIIB037) is an investigational human recombinant monoclonal antibody (mAb) in development for the treatment of early Alzheimer’s disease (AD).

sulopenem

Company: Iterum Therapeutics plc
Treatment for: Bacterial Infection

Sulopenem is an orally bioavailable, broad-spectrum penem β-lactam antibiotic in development for the treatment of infections caused by multi-drug resistant bacteria.

Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem - January 25, 2021
Iterum Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem - November 30, 2020

odevixibat

Company: Albireo Pharma, Inc.
Treatment for: Progressive Familial Intrahepatic Cholestasis (PFIC)

Odevixibat is a once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) in development for the treatment of rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome.

Albireo Announces U.S. FDA Acceptance of New Drug Application for Odevixibat - January 25, 2021
Albireo Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixibat for PFIC - December 8, 2020

Trudhesa (dihydroergotamine mesylate) - formerly INP104

Company: Impel NeuroPharma
Treatment for: Migraine

Trudhesa (dihydroergotamine mesylate) is a nasally administered dihydroergotamine (DHE) formulation in development for the acute treatment of migraine headaches.

Kyzatrex (testosterone undecanoate)

Company: Marius Pharmaceuticals
Treatment for: Hypogonadism -- Male

Kyzatrex (testosterone undecanoate) is a novel, soft gelatin capsule testosterone formulation in development for the treatment of primary and secondary hypogonadism in adult men.

Marius Pharmaceuticals Submits New Drug Application to U.S. FDA for Kyzatrex Next-generation Oral Testosterone Replacement Therapy in Male Patients with Hypogonadism - January 5, 2021

somatrogon

Company: Pfizer Inc.
Treatment for: Pediatric Growth Hormone Deficiency

Somatrogon is an investigational, long-acting human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD).

US FDA Accepts Regulatory Submission from Pfizer and OPKO for Review of Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency - January 4, 2021

teplizumab

Company: Provention Bio, Inc.
Treatment for: Prevention of Type 1 Diabetes

Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) in development for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals.

ALKS 3831 (olanzapine and samidorphan)

Company: Alkermes plc
Treatment for: Schizophrenia, Bipolar Disorder

ALKS 3831 (olanzapine and samidorphan) is an investigational, once-daily, oral atypical antipsychotic combination of an established antipsychotic agent (olanzapine) and a novel μ-opioid receptor antagonist (samidorphan) in development for the treatment of schizophrenia and bipolar I disorder.

FDA Accepts Alkermes' Resubmission of New Drug Application for ALKS 3831 - December 29, 2020
Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review - November 17, 2020
FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder - October 9, 2020
Alkermes Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder - January 28, 2020
Alkermes Submits New Drug Application to U.S. Food and Drug Administration for ALKS 3831 for Treatment of Schizophrenia and Bipolar I Disorder - November 19, 2019

MydCombi (phenylephrine and tropicamide) Ophthalmic Solution

Company: Eyenovia, Inc.
Treatment for: Pharmacologic Mydriasis

MydCombi (phenylephrine and tropicamide) is a fixed-combination microdose formulation of the approved mydriatics phenylephrine and tropicamide in development for pharmacologic mydriasis in the eye care practitioner’s office.

Eyenovia Submits New Drug Application to FDA for Pharmacologic Mydriasis with MydCombi - December 29, 2020

surufatinib

Company: Hutchison China MediTech Limited
Treatment for: Neuroendocrine Carcinoma

Surufatinib is a novel, oral angio-immuno kinase inhibitor in development for the treatment of pancreatic and non-pancreatic neuroendocrine tumors (“NET”).

Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors - December 28, 2020

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New Drug Applications Archive

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