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.

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empagliflozin and linagliptin

Company: Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company
Treatment for: Diabetes Type 2

Empagliflozin and linagliptin is a sodium glucose co-transporter-2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP-4) inhibitor combination in development for the treatment of adults with type 2 diabetes.

atazanavir and cobicistat

Company: Bristol-Myers Squibb Company
Treatment for: HIV Infection

Atazanavir and cobicistat is a fixed-dose combination of a protease inhibitor, and an investigational pharmacokinetic enhancer in development for the treatment of HIV-1 infection.

Rytary (carbidopa and levodopa) Extended Release Capsules - formerly IPX066

Company: Impax Laboratories, Inc.
Treatment for: Parkinson's Disease

Rytary (carbidopa and levodopa) is an extended release capsule formulation of carbidopa and levodopa in development for the treatment of Parkinson's Disease.

ledipasvir and sofosbuvir

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

Ledipasvir/Sofosbuvir is a once-daily NS5A inhibitor and nucleotide analog polymerase inhibitor fixed-dose combination in development for the treatment of chronic hepatitis C genotype 1 infection.

daclatasvir

Company: Bristol-Myers Squibb Company
Treatment for: Chronic Hepatitis C

Daclatasvir is an NS5A replication complex inhibitor in development for the treatment of Hepatitis C.

Dolizem (diltiazem hydrochloride) Topical Cream

Company: Ventrus Biosciences
Treatment for: Anal Fissure and Fistula

Dolizem (diltiazem) is an investigational topical calcium-channel blocker applied perianally to treat pain related to anal fissure.

cobicistat and darunavir

Company: Janssen Research & Development, LLC
Treatment for: HIV Infection

Darunavir/Cobicistat is a once-daily fixed-dose antiretroviral combination containing a protease inhibitor and an investigational pharmacokinetic enhancer in development for the treatment of HIV-1 infection.

AVP-825 (sumatriptan)

Company: Avanir Pharmaceuticals, Inc.
Treatment for: Migraine

AVP-825 (sumatriptan) is an investigational fast-acting, dry-powder intranasal form of sumatriptan in development for the treatment of migraine.

Ztilido (lidocaine) Patch

Company: Scilex Pharmaceuticals, Inc.
Treatment for: Postherpetic Neuralgia

Ztilido (lidocaine patch 1.8%) is a topical anesthetic in development for the treatment of post-herpetic neuralgia, also referred to as after-shingles pain.

Triferic (ferric pyrophosphate citrate)

Company: Rockwell Medical, Inc.
Treatment for: Anemia Associated with Chronic Renal Failure

Triferic (ferric pyrophosphate citrate) is an investigational iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis.

Ryanodex (dantrolene)

Company: Eagle Pharmaceuticals, Inc.
Treatment for: Malignant Hyperthermia

Ryanodex (dantrolene) is a new concentrated formulation of the skeletal muscle relaxant dantrolene in development for the treatment of malignant hyperthermia.

Envarsus (tacrolimus)

Company: Veloxis Pharmaceuticals
Treatment for: Organ Transplant -- Rejection Prophylaxis

Envarsus (tacrolimus) is a once-daily immunosuppressant in development for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants.

empagliflozin

Company: Boehringer Ingelheim and Eli Lilly and Company
Treatment for: Diabetes Type 2

Empagliflozin is an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor in development for the treatment of type 2 diabetes.

donepezil and memantine

Company: Forest Laboratories, Inc. and Adamas Pharmaceuticals Inc.
Treatment for: Alzheimer's Disease

Memantine ER/Donepezil is a fixed-dose combination (FDC) in development for the treatment of moderate to severe dementia of the Alzheimer’s type.

gevokizumab

Company: XOMA Corporation
Treatment for: Uveitis

Gevokizumab is a potent monoclonal antibody in development for the treatment of non-infectious uveitis.

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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