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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.

Luxturna (voretigene neparvovec)

Company: Spark Therapeutics
Treatment for: Biallelic RPE65-Mediated Inherited Retinal Disease

Luxturna (voretigene neparvovec) is an investigational adeno-associated viral (AAV) vector gene therapy for the treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease (IRD).

semaglutide

Company: Novo Nordisk
Treatment for: Diabetes Type 2

Semaglutide is a once-weekly glucagon-like peptide-1 (GLP-1) analog in development for the treatment of adults with type 2 diabetes.

CL-108 (acetaminophen, hydrocodone and promethazine)

Company: Charleston Laboratories, Inc. and Daiichi Sankyo, Inc.
Treatment for: Pain, Nausea/Vomiting

CL-108 (acetaminophen, hydrocodone and promethazine) is an analgesic and antihistamine fixed-dose combination in development for the relief of moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV).

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.

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.

DSUVIA (sufentanil) Sublingual Tablets - formerly ARX-04

Company: AcelRx Pharmaceuticals, Inc.
Treatment for: Pain

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

apalutamide

Company: Janssen Biotech, Inc.
Treatment for: Prostate Cancer

Apalutamide is an investigational, next generation oral androgen receptor inhibitor in development for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC).

Tavalisse (fostamatinib)

Company: Rigel Pharmaceuticals, Inc.
Treatment for: Immune Thrombocytopenia

Fostamatinib is an investigational oral spleen tyrosine kinase (SYK) inhibitor in development for the treatment of patients with chronic and persistent immune thrombocytopenia (ITP).

KIT-302 (amlodipine and celecoxib)

Company: Kitov Pharmaceuticals Holdings Ltd.
Treatment for: Hypertension, Osteoarthritis

KIT-302 (amlodipine and celecoxib) is a calcium channel blocker and nonsteroidal anti-inflammatory drug combination in development for the treatment of both hypertension and pain associated with osteoarthritis.

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.

Rexista (oxycodone hydrochloride) Extended-Release Tablets

Company: Intellipharmaceutics International Inc.
Treatment for: Pain

Rexista (oxycodone hydrochloride extended release) is an abuse and alcohol-deterrent controlled-release formulation of oxycodone hydrochloride in development for the relief of moderate to severe pain.

Linhaliq (ciprofloxacin liposomal) for Inhalation

Company: Aradigm Corporation

Linhaliq is an inhalation formulation of liposome encapsulated and unencapsulated ciprofloxacin in development for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa.

Plivensia (sirukumab)

Company: Janssen Biotech, Inc.
Treatment for: Rheumatoid Arthritis

Plivensia (sirukumab) is a human anti-interleukin-6 monoclonal antibody in development for the treatment of rheumatoid arthritis.

CAM2038 (buprenorphine)

Company: Camurus and Braeburn Pharmaceuticals
Treatment for: Opiate Dependence

CAM2038 (buprenorphine) is a long-acting partial opioid agonist formulation in development for the treatment of opioid dependence.

Shingrix (herpes zoster subunit vaccine )

Company: GlaxoSmithKline
Treatment for: Herpes Zoster -- Prophylaxis

Shingrix (herpes zoster subunit vaccine) is a non-live, recombinant subunit vaccine in development to help prevent herpes zoster (shingles).

ZTlido (lidocaine) Patch - formerly Ztilido

Company: Scilex Pharmaceuticals, Inc.
Treatment for: Postherpetic Neuralgia

ZTlido (lidocaine patch 1.8%) is a transdermal anesthetic formulation in development for the treatment of postherpetic neuralgia.

elagolix

Company: AbbVie, Inc.
Treatment for: Endometriosis

Elagolix is an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist in development for the management of endometriosis with associated pain.

Admelog (insulin lispro) Injection

Company: Sanofi
Treatment for: Diabetes Type 1, Diabetes Type 2

Admelog (insulin lispro) is a follow-on insulin product (referenced to Humalog) in development for the treatment of patients with type 1 and type 2 diabetes.

volanesorsen

Company: Akcea Therapeutics, Inc.
Treatment for: Familial Chylomicronemia Syndrome

Volanesorsen is an antisense oligonucleotide apolipoprotein C-III (ApoC-III) inhibitor in development for the treatment of familial chylomicronemia syndrome (FCS).

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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