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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 How Drugs are Developed and Approved page.


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.


Company: EMD Serono Inc.
Treatment for: Merkel Cell Carcinoma

Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody in development for the treatment of metastatic Merkel cell carcinoma.


Company: Amicus Therapeutics
Treatment for: Fabry Disease

Migalastat (AT1001) is an investigational pharmacological chaperone in development for the treatment of Fabry disease.

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.

fluticasone furoate, umeclidinium and vilanterol

Company: GlaxoSmithKline
Treatment for: Chronic Obstructive Pulmonary Disease

FF/UMEC/VI (fluticasone furoate/umeclidinium/vilanterol) is an investigational once-daily ‘closed’ triple combination therapy comprising an inhaled corticosteroid, a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA), in development for the treatment of patients with chronic obstructive pulmonary disease (COPD).

Vitaros (alprostadil) Cream - formerly Alprox-TD

Company: Apricus Biosciences, Inc.
Treatment for: Erectile Dysfunction

Vitaros (alprostadil) is a topical vasodilator cream in development for the treatment of erectile dysfunction.

NT-0201 (amphetamine) Extended-Release Liquid Suspension

Company: Neos Therapeutics, Inc.
Treatment for: Attention-Deficit Hyperactivity Disorder (ADHD)

NT-0201 (amphetamine) is an extended-release liquid suspension amphetamine formulation in development for the treatment of ADHD.

ABP 215 (bevacizumab)

Company: Amgen Inc.
Treatment for: Non-Small Cell Lung Cancer, Colorectal Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Breast Cancer, Ovarian Cancer

ABP 215 (bevacizumab) is an anti-vascular endothelial growth factor A (anti-VEGF) monoclonal antibody biosimilar to Avastin (bevacizumab) in development for the treatment of non-squamous non-small cell lung cancer (NSCLC) and other cancers.

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.

Solithera (solithromycin)

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).


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.


Company: Ariad Pharmaceuticals, Inc.
Treatment for: Non-Small Cell Lung Cancer

Brigatinib is an investigational anaplastic lymphoma kinase (ALK) inhibitor in development for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease is resistant to crizotinib.


Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Rheumatoid Arthritis

Sarilumab is an investigational interleukin-6 receptor (IL-6R) antibody in development for the treatment of patients with rheumatoid arthritis.

Spinraza (nusinersen)

Company: Biogen
Treatment for: Spinal Muscular Atrophy

Spinraza (nusinersen) is an antisense oligonucleotide in development for the treatment of spinal muscular atrophy.

Macrilen (macimorelin acetate)

Company: Aeterna Zentaris Inc.
Treatment for: Adult Human Growth Hormone Deficiency

Macrilen (macimorelin) is a ghrelin agonist in development for use in evaluating adult growth hormone deficiency (AGHD).


Company: Portola Pharmaceuticals Inc.

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.

Baxdela (delafloxacin)

Company: Melinta Therapeutics
Treatment for: Gonococcal Infection -- Uncomplicated, Skin and Structure Infection

Baxdela (delafloxacin) is a novel investigational fluoroquinolone in development for the treatment of uncomplicated gonorrhea, and acute bacterial skin and skin structure infections.

Xadago (safinamide)

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.

SD-809 (deutetrabenazine)

Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Huntington Disease, Tardive Dyskinesia

SD-809 (deutetrabenazine) is an investigational vesicular monoamine 2 transporter (VMAT2) inhibitor intended for the treatment of chorea associated with Huntington disease.

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

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