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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.

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Lyxumia (lixisenatide)

Company: Sanofi
Treatment for: Diabetes Type 2

Lyxumia (lixisenatide) is a once-daily prandial GLP-1 receptor agonist in development for the treatment of adults with type 2 diabetes mellitus.

Repatha (evolocumab)

Company: Amgen Inc.
Treatment for: High Cholesterol

Repatha (evolocumab) is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in development for the treatment of patients with high cholesterol.

Praluent (alirocumab)

Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: High Cholesterol

Praluent (alirocumab) an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in development for the treatment of patients with high cholesterol.

daclatasvir

Company: Bristol-Myers Squibb Company
Treatment for: Chronic Hepatitis C

Daclatasvir is an NS5A replication complex inhibitor in development for the treatment of Hepatitis C.

ATX-101 (deoxycholic acid)

Company: Kythera Biopharmaceuticals, Inc.
Treatment for: Submental Fullness

ATX-101 (deoxycholic acid) is a formulation of a derived version of deoxycholic acid (a naturally occurring molecule in the body that aids in the breakdown of dietary fat) in development for the treatment of submental fullness, or double chin.

Zalviso (sufentanil) Sublingual Microtablet System

Company: AcelRx Pharmaceuticals, Inc.
Treatment for: Pain

Zalviso (sufentanil sublingual microtablet system) is a patient-activated, non-invasive analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting.

Kovaltry (factor VIII (recombinant))

Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Hemophilia A

Kovaltry (factor VIII (recombinant)) is an investigational plasma protein-free compound in development for the treatment of hemophilia A.

Uptravi (selexipag)

Company: Actelion Ltd.
Treatment for: Pulmonary Hypertension

Uptravi (selexipag) is a potent, orally available, selective IP prostacyclin receptor agonist in development for the treatment of pulmonary arterial hypertension.

idarucizumab

Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Reversal Agent for Pradaxa

Idarucizumab is a humanized antibody fragment, or Fab, being investigated as a specific reversal agent for the anticoagulant effect of dabigatran (Pradaxa).

lifitegrast

Company: Shire plc
Treatment for: Dry Eye Disease

Lifitegrast is a topical integrin antagonist in development for the treatment of dry eye disease.

Xadago (safinamide)

Company: Newron Pharmaceuticals S.p.A.
Treatment for: Parkinson's Disease

Xadago (safinamide) is an alpha-aminoamide in development as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson’s disease.

ZMapp

Company: Mapp Biopharmaceutical, Inc.
Treatment for: Ebola Virus Disease

ZMapp is a combination of three chimeric monoclonal antibodies manufactured in the Nicotiana benthamiana tobacco plant that has been used in the experimental treatment of Ebola virus disease.

AuriPro (ciprofloxacin)

Company: Otonomy, Inc.
Treatment for: Otitis Media

AuriPro (ciprofloxacin) is a sustained-exposure otic fluoroquinolone formulation in development for the treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery.

Belbuca (buprenorphine hydrochloride) Buccal Film

Company: Endo Pharmaceuticals Inc.
Treatment for: Chronic Pain

Belbuca (buprenorphine) is an opioid analgesic buccal film formulation in development for the management of chronic pain.

TAS-102 (tipiracil hydrochloride and trifluridine)

Company: Taiho Oncology, Inc.
Treatment for: Colorectal Cancer

TAS-102 (trifluridine and tipiracil hydrochloride) is an antineoplastic nucleoside analog and thymidine phosphorylase inhibitor combination in development for the treatment of refractory metastatic colorectal cancer (mCRC).

cobimetinib

Company: Genentech
Treatment for: Melanoma - Metastatic

Cobimetinib is an investigational MEK inhibitor in development for the combination treatment of advanced melanoma.

Reolysin (pelareorep)

Company: Oncolytics Biotech Inc.
Treatment for: Ovarian Cancer, Pancreatic Cancer

Reolysin (pelareorep) is a proprietary formulation of the human reovirus (Respiratory Enteric Orphan Virus) in development for the treatment of various cancers and cell proliferative disorders.

flibanserin

Company: Sprout Pharmaceuticals, Inc.
Treatment for: Hypoactive Sexual Desire Disorder

Flibanserin is a novel, non-hormonal, multifunctional serotonin agonist antagonist (MSAA) in development for the treatment of hypoactive sexual desire disorder in premenopausal women.

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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