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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.

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.

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).

bictegravir, emtricitabine and tenofovir alafenamide

Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Bictegravir, emtricitabine and tenofovir alafenamide is an investigational integrase strand transfer inhibitor and emtricitabine/tenofovir alafenamide (FTC/TAF) combination in development for the treatment of HIV-1 infection in adults.

Yuvvexy (estradiol) - formerly TX-004HR

Company: TherapeuticsMD, Inc.
Treatment for: Dyspareunia

Yuvvexy (estradiol) is an investigational bio-identical 17β-estradiol softgel capsule vaginal formulation for the treatment of dyspareunia (vaginal pain during sexual intercourse) due to menopause.

Kevzara (sarilumab) Injection

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

Kevzara (sarilumab) is an interleukin-6 receptor (IL-6R) antibody for the treatment of adults with rheumatoid arthritis.

DE-109 (sirolimus) Intravitreal Injection

Company: Santen Pharmaceutical Co., Ltd.
Treatment for: Uveitis

DE-109 (sirolimus), an mTOR inhibitor, is an investigational first-in-class targeted, immunoregulator in development for the of non-infectious uveitis of the posterior segment (NIU-PS).

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: 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 hydrochloride) Ophthalmic Solution - formerly AC-170

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

Zerviate (cetirizine hydrochloride) is a histamine-1 (H1) receptor antagonist ophthalmic formulation for the treatment of ocular itching associated with allergic conjunctivitis.

Rebinyn (coagulation factor IX (recombinant), glycopegylated) Injection

Company: Novo Nordisk
Treatment for: Hemophilia B

Rebinyn (coagulation factor IX (recombinant), glycopegylated is an extended-half-life recombinant DNA-derived coagulation factor IX concentrate for the treatment and control of bleeding episodes in patients with 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.

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

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