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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.

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).

talazoparib

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.

lumateperone

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.

bremelanotide

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.

Duaklir (aclidinium bromide and formoterol fumarate)

Company: Circassia Pharmaceuticals plc
Treatment for: Chronic Obstructive Pulmonary Disease

Duaklir Pressair (aclidinium bromide and formoterol fumarate) is a long-acting muscarinic antagonist (LAMA) and long-acting beta agonist (LABA) fixed dose combination maintenance bronchodilator in development for the treatment of COPD.

brexanolone

Company: Sage Therapeutics
Treatment for: Postpartum Depression

Brexanolone (SAGE-547) is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors in development for the treatment of postpartum depression (PPD).

mogamulizumab

Company: Kyowa Hakko Kirin Co., Ltd.
Treatment for: Mycosis Fungoides; Sézary Syndrome

Mogamulizumab is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4) in development for the treatment of Mycosis Fungoides (MF) and Sézary Syndrome (SS), the most common subtypes of cutaneous T-cell lymphoma (CTCL).

larotrectinib

Company: Loxo Oncology, Inc.
Treatment for: Solid Tumors

Larotrectinib is an oral selective tropomyosin receptor kinase (TRK) inhibitor in clinical development for the treatment solid tumors harboring NTRK-fusion proteins.

gilteritinib

Company: Astellas Pharma Inc.
Treatment for: Acute Myeloid Leukemia

Gilteritinib is an inhibitor of the tyrosine kinases FLT3/AXL in development for the treatment of patients with FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia (AML).

DSUVIA (sufentanil) Sublingual Tablets - formerly ARX-04

Company: AcelRx Pharmaceuticals, Inc.
Treatment for: Pain

DSUVIA (sufentanil) is an investigational synthetic opioid analgesic formulation administered sublingually for the treatment of patients experiencing moderate-to-severe acute pain in a medically supervised setting.

fremanezumab

Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Migraine Prophylaxis

Fremanezumab is a fully-humanized monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) ligand in development for the preventive treatment of migraine.

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.

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.

Ryaltris (mometasone furoate and olopatadine hydrochloride) Nasal Spray

Company: Glenmark Pharmaceuticals, Inc.
Treatment for: Allergic Rhinitis

Ryaltris (mometasone and olopatadine) is an investigational steroid and antihistamine fixed-dose combination nasal spray in development as a treatment for seasonal allergic rhinitis (SAR) in patients 12 years of age and older.

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.

Roclatan (latanoprost and netarsudil)

Company: Aerie Pharmaceuticals, Inc.

Roclatan (latanoprost/netarsudil ophthalmic solution) is a fixed dose combination of two approved drugs -- the prostaglandin analog latanoprost (Xalatan) and Rho kinase inhibitor netarsudil (Rhopressa) -- in development for the treatment of patients with glaucoma or ocular hypertension.

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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