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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.

CTL019 (tisagenlecleucel-T)

Company: Novartis Pharmaceuticals Corporation
Treatment for: Acute Lymphoblastic Leukemia

CTL019 (tisagenlecleucel-T) is an investigational chimeric antigen receptor T cell (CAR-T) therapy in development for use in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).


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

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


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.

Dexycu (dexamethasone)

Company: Icon Bioscience Inc.
Treatment for: Postoperative Ocular Inflammation

Dexycu (dexamethasone) is an investigational, long-acting, injectable corticosteroid formulation delivering dexamethasone into the anterior chamber of the eye for the treatment of inflammation associated with cataract surgery.

Zerviate (cetirizine) Ophthalmic Solution - formerly AC-170

Company: Nicox S.A.
Treatment for: Allergic Conjunctivitis

Zerviate (cetirizine) is a second generation antihistamine topical ophthalmic formulation in development for the treatment of ocular itching associated with allergic conjunctivitis.

nonacog beta pegol

Company: Novo Nordisk
Treatment for: Hemophilia B

Nonacog beta pegol is an investigational glycoPEGylated extended-half-life recombinant factor IX product in development for the treatment of hemophilia B.

Vyxeos (cytarabine and daunorubicin) Injection

Company: Jazz Pharmaceuticals plc
Treatment for: Acute Myeloid Leukemia

Vyxeos (cytarabine and daunorubicin liposome injection) is an investigational nano-scale liposome co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio in development for the treatment of acute myeloid leukemia.

KTE-C19 (axicabtagene ciloleucel)

Company: Kite Pharma, Inc.
Treatment for: non-Hodgkin's Lymphoma

KTE-C19 (axicabtagene ciloleucel) is an investigational anti-CD19 CAR-T therapy in development for the treatment of patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant.

KTE-C19 therapy involves the engineering of a patient's T cells to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. The T cells are then redirected to kill the cancer cells.

Solosec (secnidazole) Oral Granules

Company: Symbiomix Therapeutics
Treatment for: Bacterial Vaginosis

Solosec (secnidazole) is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties anticipated to be the first and only single-dose oral therapy approved for the treatment of bacterial vaginosis (BV).

Vesneo (latanoprostene bunod) Ophthalmic Solution

Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Glaucoma (Open Angle), Intraocular Hypertension

Vesneo (latanoprostene bunod ophthalmic solution) is a nitric oxide donating prostaglandin receptor agonist in development for the treatment of patients with open angle glaucoma or ocular hypertension.


Company: Array BioPharma
Treatment for: NRAS-Mutant Melanoma

Binimetinib is a late-stage small molecule MEK inhibitor in development for the treatment of advanced NRAS-mutant melanoma.


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: Celgene Corporation
Treatment for: Acute Myeloid Leukemia

Enasidenib is a first-in-class, oral, targeted inhibitor of mutant isocitrate dehydrogenase 2 (IDH2) in development for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation.


Company: Merck
Treatment for: Diabetes Type 2

Ertugliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor in development to help improve glycemic control in adults with type 2 diabetes.

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

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