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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: Eli Lilly and Company
Treatment for: Migraine

Lasmiditan is an investigational selective serotonin 5-HT1F agonist in development for the acute treatment of migraine with or without aura in adults.

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.

ALKS 5461 (buprenorphine and samidorphan)

Company: Alkermes plc
Treatment for: Major Depressive Disorder

ALKS 5461 (buprenorphine and samidorphan) is a novel opioid modulator, combining a partial opioid agonist with an opioid antagonist to rebalance brain function in patients with treatment-resistant depression.

HTX-011 (bupivacaine and meloxicam)

Company: Heron Therapeutics, Inc.
Treatment for: Postoperative Pain

HTX-011 (bupivacaine and meloxicam) is an investigational fixed-dose combination of the local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam in development for the management of postoperative pain.

Dengvaxia (dengue vaccine)

Company: Sanofi Pasteur
Treatment for: Prevention of Dengue

Dengvaxia (dengue vaccine) is a live recombinant tetravalent dengue vaccine in development for the prevention of dengue.

Edsivo (celiprolol)

Company: Acer Therapeutics Inc.
Treatment for: Vascular Ehlers-Danlos Syndrome

Edsivo (celiprolol) is a β-blocker (β1-andrenoceptor antagonist with partial β2 agonist activity) in development for the treatment of vascular Ehlers-Danlos syndrome (vEDS).

dolutegravir and lamivudine Tablets

Company: ViiV Healthcare
Treatment for: HIV Infection

Dolutegravir and lamivudine is an investigational two-drug regimen of the approved drugs dolutegravir (Tivicay) and lamivudine (Epivir) in development for the treatment of HIV-1 infection.


Company: Shire plc
Treatment for: Chronic Idiopathic Constipation

Prucalopride is a selective serotonin type 4 (5‑HT4) receptor agonist in development for the treatment of chronic idiopathic constipation (CIC) in adults.

KPI-121 0.25% (loteprednol etabonate)

Company: Kala Pharmaceuticals, Inc.
Treatment for: Dry Eye Disease

KPI-121 0.25% (loteprednol etabonate) is an ophthalmic corticosteroid formulation in development for the temporary relief of signs and symptoms of dry eye disease.

Bryhali (halobetasol propionate) Lotion - formerly Jemdel

Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis

Bryhali (halobetasol propionate) is a high-potency topical corticosteroid formulation for the treatment of plaque psoriasis in adults.


Company: Novartis
Treatment for: Multiple Sclerosis

Siponimod is an investigational, sphingosine-1-phosphate receptor modulator in development for the treatment of secondary progressive multiple sclerosis.

Barhemsys (amisulpride) Injection - formerly Baremsis

Company: Acacia Pharma
Treatment for: Nausea/Vomiting -- Postoperative

Barhemsys (amisulpride) is a dopamine antagonist in development for the management of post-operative nausea & vomiting (PONV).


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.

Feraccru (ferric maltol)

Company: Shield Therapeutics plc
Treatment for: Iron Deficiency

Feraccru (ferric maltol) is a non-salt formulation of ferric iron in development for the treatment of iron deficiency.


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

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

Valtoco (diazepam) Nasal Spray

Company: Neurelis, Inc.
Treatment for: Epilepsy

Valtoco (diazepam) is an investigational benzodiazepine nasal spray formulation in development for the treatment of epilepsy cluster seizures.


Company: Janssen Pharmaceuticals, Inc.
Treatment for: Urothelial Carcinoma

Erdafitinib is an investigational, once-daily oral pan-fibroblast growth factor receptor (FGFR) in development for the treatment of patients with locally advanced or metastatic urothelial cancer.

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

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