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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.

Tlando (testosterone) - formerly LPCN 1021

Company: Lipocine Inc.
Treatment for: Hypogonadism -- Male

Tlando (testosterone) is an oral testosterone replacement therapy in development for the treatment of males with conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.

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.

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.

Plivensia (sirukumab)

Company: Janssen Biotech, Inc.
Treatment for: Rheumatoid Arthritis

Plivensia (sirukumab) is a human anti-interleukin-6 monoclonal antibody in development for the treatment of rheumatoid arthritis.

acalabrutinib

Company: AstraZeneca
Treatment for: Mantle Cell Lymphoma

Acalabrutinib is an investigational, highly selective, potent, Bruton tyrosine kinase (BTK) inhibitor in development for the treatment of mantle cell lymphoma (MCL).

Linhaliq (ciprofloxacin liposomal) for Inhalation

Company: Aradigm Corporation

Linhaliq is an inhalation formulation of liposome encapsulated and unencapsulated ciprofloxacin in development for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa.

Twirla (ethinyl estradiol and levonorgestrel) Transdermal System

Company: Agile Therapeutics, Inc.
Treatment for: Contraception

Twirla (ethinyl estradiol and levonorgestrel transdermal system) is an investigational low-dose combined hormonal contraceptive.

baricitinib

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.

Lusduna Nexvue (insulin glargine) - formerly MK-1293

Company: Merck & Co., Inc.
Treatment for: Diabetes Type 1, Diabetes Type 2

Lusduna Nexvue (insulin glargine injection) is a follow-on biologic (biosimilar) to Lantus in development for the treatment of patients with type 1 and type 2 diabetes.

Yonsa (abiraterone acetate)

Company: Churchill Pharmaceuticals, LLC
Treatment for: Prostate Cancer

Yonsa (abiraterone acetate) is an improved ultramicrosize formulation of the oral CYP17 inhibitor abiraterone acetate (approved as Zytiga) in development for the combination treatment of metastatic castration-resistant prostate cancer.

CAM2038 (buprenorphine)

Company: Camurus and Braeburn Pharmaceuticals
Treatment for: Opiate Dependence

CAM2038 (buprenorphine) is a long-acting partial opioid agonist formulation in development for the treatment of opioid dependence.

Aimovig (erenumab)

Company: Amgen Inc.
Treatment for: Migraine Prophylaxis

Aimovig (erenumab) is a human monoclonal antibody that inhibits the receptor for calcitonin gene-related peptide (CGRP) in development for the prevention of episodic and chronic migraine.

Evenity (romosozumab)

Company: Amgen Inc.
Treatment for: Osteoporosis

Evenity (romosozumab) is an anti-sclerostin monoclonal antibody in development for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

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).

abemaciclib

Company: Eli Lilly and Company
Treatment for: Breast Cancer

Abemaciclib is a selective ATP-competitive inhibitor of cyclin dependent kinases (CDK) 4 and 6 in development for the treatment of metastatic breast cancer.

migalastat

Company: Amicus Therapeutics
Treatment for: Fabry Disease

Migalastat (AT1001) is an investigational pharmacological chaperone in development for the treatment of Fabry disease.

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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