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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.

NKTR-181 (loxicodegol)

Company: Nektar Therapeutics
Treatment for: Pain

NKTR-181 (loxicodegol) 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.

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.


Company: Karyopharm Therapeutics Inc.
Treatment for: Multiple Myeloma

Selinexor (KPT-330) is a first in class Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist in development for the treatment of patients with penta-refractory multiple myeloma.

Evenity (romosozumab)

Company: Amgen Inc.
Treatment for: Osteoporosis

Evenity (romosozumab) is an anti-sclerostin monoclonal antibody in development for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Krintafel (tafenoquine) Tablets

Company: GlaxoSmithKline
Treatment for: Malaria

Krintafel (tafenoquine) is an 8-aminoquinoline derivative antimalarial for the radical cure (prevention of relapse) of Plasmodium vivax malaria.

Dextenza (dexamethasone) Intracanalicular Depot

Company: Ocular Therapeutix, Inc.
Treatment for: Postoperative Ocular Inflammation

Dextenza (dexamethasone insert) is an investigational intracanalicular depot corticosteroid formulation designed to deliver sustained release dexamethasone to the ocular surface for up to 30 days after ophthalmic surgery for the treatment of post-surgical ocular inflammation and pain.


Company: Pfizer Inc.
Treatment for: Acute Myeloid Leukemia

Glasdegib (PF-04449913) is an oral, smoothened (SMO) inhibitor that disrupts the hedgehog (Hh) pathway. Glasdegib is being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in combination with low-dose cytarabine.

Scenesse (afamelanotide)

Company: Clinuvel Pharmaceuticals Ltd.
Treatment for: Erythropoietic Protoporphyria

Scenesse (afamelanotide) is a selective agonist of the melanocortin 1 receptor (MC1R) in development for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).

ALXN1210 (ravulizumab)

Company: Alexion Pharmaceuticals, Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria

ALXN1210 (ravulizumab) is an investigational long-acting C5 complement inhibitor in development for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Duobrii (halobetasol propionate and tazarotene) Lotion - formerly IDP-118

Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis

Duobrii (halobetasol propionate and tazarotene) is a corticosteroid and retinoid combination in development for the topical treatment of plaque psoriasis.

iclaprim Intravenous Injection

Company: Motif Bio plc
Treatment for: Skin and Structure Infection

Iclaprim is an investigational broad-spectrum diaminopyrimidine antibiotic in development for the treatment of acute bacterial skin and skin structure infections (ABSSSIs).

APL-130277 (apomorphine) Sublingual Film

Company: Sunovion Pharmaceuticals Inc.
Treatment for: Parkinson's Disease

APL-130277 (apomorphine sublingual film) is a novel formulation of the approved dopamine agonist apomorphine in development for the on-demand management of OFF episodes associated with Parkinson’s disease (PD).


Company: Pfizer Inc.
Treatment for: Breast Cancer

Talazoparib is an oral poly ADP ribose polymerase (PARP) inhibitor in development for the treatment of germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.


Company: Intra-Cellular Therapies, Inc.
Treatment for: Schizophrenia

Lumateperone is first-in-class antipsychotic in development for the treatment of schizophrenia.

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 gastroparesis in women.


Company: Palatin Technologies, Inc.
Treatment for: Hypoactive Sexual Desire Disorder

Bremelanotide is a melanocortin receptor agonist in development for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.

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

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