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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.

Twirla (ethinyl estradiol and levonorgestrel) Transdermal System

Company: Agile Therapeutics, Inc.
Treatment for: Contraception

Twirla (ethinyl estradiol and levonorgestrel transdermal system) is an investigational low-dose combined hormonal contraceptive patch in development as a form of birth control. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch.

Talicia (amoxicillin, omeprazole and rifabutin) Capsules

Company: RedHill Biopharma Ltd.
Treatment for: Helicobacter pylori Infection

Talicia (RHB-105) is a fixed-dose oral combination of rifabutin and amoxicillin (both antibiotics), and omeprazole (a proton pump inhibitor (PPI)), in development for the treatment of Helicobacter pylori infection.

Zygel (cannabidiol) Gel

Company: Zynerba Pharmaceuticals, Inc.
Treatment for: Behavioral Symptoms associated with Fragile X Syndrome

Zygel (cannabidiol gel) is a transdermal gel formulation of cannabidiol (CBD) in development for the treatment of behavioral symptoms associated with Fragile X Syndrome (FXS).

bempedoic acid

Company: Esperion Therapeutics, Inc.
Treatment for: Hypercholesterolemia

Bempedoic acid is a first-in-class, ATP Citrate Lyase (ACL) inhibitor in development for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C).

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).

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.

Contepo (fosfomycin)

Company: Nabriva Therapeutics plc
Treatment for: Urinary Tract Infection

Contepo (fosfomycin for injection) is an investigational epoxide antibiotic in development as a first-line treatment for complicated urinary tract infections (cUTIs), including acute pyelonephritis.

darolutamide

Company: Bayer
Treatment for: Prostate Cancer

Darolutamide is an investigational, non-steroidal androgen receptor antagonist in development for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).

cabotegravir and rilpivirine

Company: Janssen Pharmaceuticals, Inc.
Treatment for: HIV Infection

Rilpivirine and cabotegravir is a once-monthly, injectable, two-drug regimen of long-acting rilpivirine (approved in tablet form as Edurant) and the investigational integrase inhibitor cabotegravir, in development for the treatment of HIV in adults.

brolucizumab

Company: Novartis
Treatment for: Macular Degeneration

Brolucizumab (RTH258) is an anti-vascular endothelial growth factor (VEGF) single-chain antibody fragment in development for the treatment of wet age-related macular degeneration (AMD).

remimazolam

Company: Cosmo Pharmaceuticals NV
Treatment for: Anesthesia

Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic in development for use during gastrointestinal procedures.

Fintepla (fenfluramine)

Company: Zogenix, Inc.
Treatment for: Dravet Syndrome

Fintepla ((ZX008, low-dose fenfluramine) is an amphetamine derivative in development for the treatment of seizures associated with Dravet syndrome.

luspatercept

Company: Celgene Corporation

Luspatercept is a first-in-class erythroid maturation agent (EMA) in development for the treatment of myelodysplastic syndromes (MDS)-associated anemia and beta-thalassemia-associated anemia.

KW-6002 (istradefylline)

Company: Kyowa Kirin, Inc.
Treatment for: Parkinson's Disease

Istradefylline (KW-6002) is an investigational adenosine A2A receptor antagonist intended for for use as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “OFF” episodes.

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.

ozanimod

Company: Celgene Corporation
Treatment for: Multiple Sclerosis, Ulcerative Colitis

Ozanimod is an investigational selective sphingosine 1-phosphate (S1P) 1 and 5 receptor modulator in development for the treatment of patients with relapsing multiple sclerosis, and ulcerative colitis.

Zynquista (sotagliflozin)

Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Diabetes Type 1

Zynquista (sotagliflozin) is an investigational dual SGLT1 and SGLT2 inhibitor for use in combination with insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.

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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