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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.

oxymetazoline hydrochloride Cream

Company: Allergan plc
Treatment for: Acne Rosacea

Oxymetazoline cream is a potent topical vasoconstrictor formulation in development for the treatment of persistent facial erythema associated with rosacea.

IDegLira (insulin degludec and liraglutide) Injection

Company: Novo Nordisk
Treatment for: Diabetes Type 2

IDegLira (insulin degludec and liraglutide) is a once-daily, single injection fixed combination of the basal insulin analogue insulin degludec (Tresiba), and the GLP-1 analogue liraglutide (Victoza), in development for the treatment of adults with type 2 diabetes.

SB2 (infliximab)

Company: Samsung Bioepis Co., Ltd.
Treatment for: Crohn's Disease -- Maintenance, Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis, Ulcerative Colitis, Plaque Psoriasis

SB2 (infliximab) is an investigational biosimilar alternative to Remicade in development for the treatment of certain serious inflammatory diseases.

Plumiaz (diazepam) Nasal Spray

Company: Acorda Therapeutics, Inc.
Treatment for: Epilepsy

Plumiaz (diazepam) is an investigational benzodiazepine nasal spray formulation in development for the treatment of epilepsy cluster seizures.

Apadaz (acetaminophen and benzhydrocodone hydrochloride) - formerly KP201

Company: KemPharm, Inc.
Treatment for: Pain

Apadaz (acetaminophen and benzhydrocodone hydrochloride) is an investigational abuse-deterrent narcotic analgesic combination in development for the short-term management of acute pain.


Company: Eli Lilly and Company
Treatment for: Soft Tissue Sarcoma

Olaratumab is a human IgG1 monoclonal antibody in development for the combination treatment of patients with advanced soft tissue sarcoma.


Company: Cempra, Inc.
Treatment for: Community Acquired Bacterial Pneumonia

Solithromycin is a next-generation oral and intravenous fluoroketolide in clinical development for the treatment of moderate to moderately-severe community acquired bacterial pneumonia (CABP).

Rayaldee (calcifediol)

Company: OPKO Health, Inc.
Treatment for: Secondary Hyperparathyroidism

Rayaldee (calcifediol modified-release) is a first-in-class oral vitamin D prohormone treatment in development for secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency.

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).

Abilify Digital (aripiprazole)

Company: Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health
Treatment for: Schizophrenia, Bipolar Disorder

Abilify Digital (aripiprazole) is a tablet formulation of an approved atypical antipsychotic embedded with an ingestible Proteus® sensor that communicates with a wearable sensor patch and a medical software application in development for measuring adherence in the treatment of adults with schizophrenia, bipolar I disorder, and major depressive disorder.


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).

Mycapssa (octreotide)

Company: Chiasma, Inc.
Treatment for: Acromegaly

Mycapssa (octreotide) is an oral formulation of the somatostatin analog octreotide (currently available as an injection) in development for the treatment of acromegaly.


Treatment for: House Dust Mite Allergy

MK-8237 is a sublingual allergy immunotherapy (SLIT) tablet in development for the treatment of house dust mite-induced allergic rhinitis with or without conjunctivitis.


Company: Radius Health, Inc.
Treatment for: Osteoporosis

Abaloparatide is a synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein) in development for the treatment of postmenopausal women with osteoporosis.


Company: Shionogi Inc.
Treatment for: Opioid-Induced Constipation

Naldemedine is an investigational peripherally-acting mu-opioid receptor antagonist in development for the treatment of opioid-induced constipation.

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

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