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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.

ZS-9 (sodium zirconium cyclosilicate)

Company: AstraZeneca
Treatment for: Hyperkalemia

ZS-9 (sodium zirconium cyclosilicate) is a crystalline lattice potassium ion-trap in development for the treatment of hyperkalemia.

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.

Ingrezza (valbenazine)

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.

AC-170 (cetirizine)

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.

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.

Dupixent (dupilumab)

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.


Company: Biogen
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.

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.


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.

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.

telotristat etiprate

Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Carcinoid Syndrome

Telotristat etiprate is an oral tryptophan hydroxylase inhibitor in development for the treatment of carcinoid syndrome.


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.

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

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