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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 page.

ponesimod

Company: Janssen Pharmaceuticals, Inc.
Treatment for: Multiple Sclerosis

Ponesimod is an investigational selective sphingosine-1-phosphate receptor 1 (S1P1) modulator in development for the treatment of adult patients with relapsing multiple sclerosis (MS).

tanezumab

Company: Pfizer Inc.
Treatment for: Osteoarthritis

Tanezumab is a nerve growth factor (NGF) inhibitor in development for the treatment of patients with chronic pain due to moderate-to-severe osteoarthritis (OA) who have experienced inadequate pain relief with other analgesics.

berotralstat

Company: BioCryst Pharmaceuticals, Inc.
Treatment for: Hereditary Angioedema

Berotralstat (BCX7353) is an oral inhibitor of plasma kallikrein in development for the prevention and treatment of hereditary angioedema (HAE).

lurbinectedin

Company: PharmaMar and Jazz Pharmaceuticals plc
Treatment for: Small Cell Lung Cancer

Lurbinectedin is a selective inhibitor of oncogenic transcription in development for the treatment of relapsed small cell lung cancer.

lisocabtagene maraleucel

Company: Bristol-Myers Squibb Company
Treatment for: Large B-Cell Lymphoma

Lisocabtagene maraleucel (liso-cel) is an investigational chimeric antigen receptor (CAR) T-cell therapy in development for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL).

ripretinib

Company: Deciphera Pharmaceuticals, Inc.
Treatment for: Gastrointestinal Stromal Tumor

Ripretinib is an investigational broad-spectrum KIT and PDGFRα inhibitor in development for the treatment of patients with advanced gastrointestinal stromal tumors (GIST).

Olinvo (oliceridine) Injection

Company: Trevena, Inc.
Treatment for: Pain

Olinvo (oliceridine) is a G protein biased ligand of the mu opioid receptor, a new class of opioid receptor modulator in development for the treatment of moderate-to-severe acute pain.

viltolarsen

Company: Nippon Shinyaku Co., Ltd.
Treatment for: Duchenne Muscular Dystrophy

Viltolarsen is an antisense oliogonucleotide in development for the treatment of patients with Duchenne muscular dystrophy who are amenable to exon 53 skipping therapy.

selpercatinib

Company: Eli Lilly and Company
Treatment for: Non-Small Cell Lung Cancer, Thyroid Cancer

Selpercatinib (LOXO-292) is a RET kinase inhibitor in development for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer.

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.

belantamab mafodotin

Company: GlaxoSmithKline plc
Treatment for: Multiple Myeloma

Belantamab mafodotin is an anti–B cell maturation antigen (BCMA) monoclonal antibody-drug conjugate in development for the treatment of patients with relapsed or refractory multiple myeloma.

Adlarity (donepezil) Transdermal System

Company: Corium, Inc.
Treatment for: Alzheimer's Disease

Adlarity (donepezil transdermal system) is an investigational, once-weekly transdermal formulation of Aricept (donepezil HCl) in development for the treatment of Alzheimer’s disease.

LIQ861 (treprostinil) Inhalation Powder

Company: Liquidia Technologies, Inc.
Treatment for: Pulmonary Arterial Hypertension (PAH)

LIQ861 (treprostinil) is an investigational inhaled dry powder formulation of treprostinil in development for the treatment of pulmonary arterial hypertension (PAH).

JZP-258 (oxybate mixed-salts) Oral Solution

Company: Jazz Pharmaceuticals plc
Treatment for: Narcolepsy

JZP-258 is a novel, low-sodium oxybate product in development for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.

Gimoti (metoclopramide) Nasal Spray

Company: Evoke Pharma, Inc.
Treatment for: Gastroparesis

Gimoti (metoclopramide) is an intranasal formulation of the approved drug metoclopramide in development for the treatment of symptoms associated with diabetic gastroparesis in women.

umbralisib

Company: TG Therapeutics, Inc.
Treatment for: Marginal Zone Lymphoma; Follicular lymphoma

Umbralisib is an oral, once-daily, dual inhibitor of PI3K-delta and CK1-epsilon in development as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL).

NKTR-181 (oxycodegol)

Company: Nektar Therapeutics
Treatment for: Pain

Development Status: NDA Withdrawn

NKTR-181 (oxycodegol) is a novel mu-opioid agonist molecule designed to have a slow rate of entry into the brain thus reducing abuse potential and CNS-mediated side effects. NKTR-181 is in development for the treatment of chronic low back pain in adult patients new to opioid therapy.

See also: Generic Approvals, New Drug Approvals, Recent Additions to Drugs.com, Alphabetical Listing of all New Drug Applications, FDA Approval Process

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