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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: Synergy Pharmaceuticals Inc.
Treatment for: Constipation -- Chronic, Irritable Bowel Syndrome

Plecanatide is a uroguanylin analog in late-stage clinical development for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C).


Company: AstraZeneca and Valeant Pharmaceuticals International, Inc.
Treatment for: Plaque Psoriasis

Brodalumab is a human anti-interleukin-17-receptor monoclonal antibody in development for the treatment of plaque psoriasis.

ABP 501 (adalimumab)

Company: Amgen Inc.
Treatment for: Plaque Psoriasis, Rheumatoid Arthritis

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody approved as Humira for the treatment of various inflammatory diseases including plaque psoriasis and rheumatoid arthritis.


Company: Eli Lilly and Company and Incyte Corporation
Treatment for: Rheumatoid Arthritis

Baricitinib is an oral selective JAK1 and JAK2 inhibitor in development for the treatment of rheumatoid arthritis.


Company: AbbVie Inc.
Treatment for: Chronic Lymphocytic Leukemia

Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor in development for the treatment of patients with chronic lymphocytic leukemia (CLL).


Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Rheumatoid Arthritis

Sarilumab is an investigational, human monoclonal antibody directed against the IL-6 receptor in development for the treatment of patients with rheumatoid arthritis.

crisaborole Topical Ointment

Company: Anacor Pharmaceuticals, Inc.
Treatment for: Atopic Dermatitis

Crisaborole is a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the treatment of mild-to-moderate atopic dermatitis.


Company: CTI BioPharma Corp.
Treatment for: Myelofibrosis

Pacritinib is an investigational oral JAK2/FLT3 multikinase inhibitor in development for the treatment of patients with myelofibrosis.

sofosbuvir and velpatasvir

Company: Gilead Sciences, Inc.
Treatment for: Chronic Hepatitis C

Sofosbuvir/velpatasvir is an investigational nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination in development for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

insulin glargine and lixisenatide

Company: Sanofi
Treatment for: Diabetes Type 2

Insulin glargine and lixisenatide is an insulin and glucagon-like peptide-1 receptor agonist (GLP-1 RA) fixed-ratio combination in development for the treatment of adults with type 2 diabetes.

Firdapse (amifampridine phosphate)

Company: Catalyst Pharmaceuticals, Inc.
Treatment for: Lambert Eaton Myasthenic Syndrome (LEMS); Congenital Myasthenic Syndromes (CMS)

Firdapse (amifampridine phosphate) is a neuronal potassium channel blocker in development for the treatment of Lambert Eaton myasthenic syndrome (LEMS) and congenital myasthenic syndromes (CMS).

Arymo ER (morphine sulfate) Extended-Release Tablets

Company: Egalet Corporation
Treatment for: Pain

Arymo ER (morphine sulfate) is an extended-release, abuse-deterrent, opioid analgesic formulation in development for the management of severe pain.

Dextenza (dexamethasone) Intracanalicular Depot

Company: Ocular Therapeutix, Inc.
Treatment for: Postoperative Ocular Inflammation

Dextenza (dexamethasone) is an investigational intracanalicular depot corticosteroid formulation delivering sustained release dexamethasone to the ocular surface for up to 30 days for the treatment of post-surgical ocular inflammation and pain.

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

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