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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simeprevir

Company: Janssen Research & Development, LLC
Treatment for: Chronic Hepatitis C

Simeprevir is an investigational NS3/4A protease inhibitor in development for the treatment of chronic hepatitis C.

trametinib

Company: GlaxoSmithKline
Treatment for: Melanoma - Metastatic

Trametinib is a MEK inhibitor in development for the treatment of unresectable or metastatic melanoma with BRAF V600 mutations.

Probuphine (buprenorphine)

Company: Titan Pharmaceuticals, Inc.
Treatment for: Opiate Dependence

Probuphine (buprenorphine) is an opioid partial agonist subdermal implant in development for the treatment of opioid dependence.

cobicistat

Company: Gilead Sciences, Inc.

Cobicistat is a potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A) which acts as a pharmacoenhancing or "boosting" agent for antiviral drugs used in the treatment of HIV infection.

elvitegravir

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

Elvitegravir is an integrase inhibitor in development for the treatment of HIV-1 infection in treatment-experienced adults.

Breo Ellipta (fluticasone and vilanterol) Inhalation Powder

Company: GlaxoSmithKline plc (GSK) and Theravance, Inc.
Treatment for: Chronic Obstructive Pulmonary Disease

Breo Ellipta (fluticasone and vilanterol) is a once-a-day inhaled corticosteroid/long-acting beta2 agonist (LABA) combination indicated for the treatment of patients with chronic obstructive pulmonary disease (COPD).

sofosbuvir

Company: Gilead Sciences
Treatment for: Chronic Hepatitis C

Sofosbuvir is a once-daily oral nucleotide analogue in development for the treatment of chronic hepatitis C virus (HCV) infection.

riociguat

Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Pulmonary Hypertension

Riociguat is an investigational oral soluble guanylate cyclase (sGC) stimulator in development for the treatment of CTEPH, PAH and other forms of pulmonary hypertension.

APF530 (granisetron)

Company: A.P. Pharma, Inc.
Treatment for: Nausea/Vomiting -- Chemotherapy Induced

APF530 is a long-acting formulation of granisetron being developed for the prevention of chemotherapy-induced nausea and vomiting.

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.

MoxDuo (morphine and oxycodone)

Company: QRxPharma Limited
Treatment for: Pain

MoxDuo (morphine and oxycodone) is a narcotic analgesic combination in development for the treatment of moderate to severe acute pain.

mechlorethamine Topical Gel

Company: Yaupon Therapeutics, Inc.
Treatment for: Mycosis Fungoides

Mechlorethamine gel is an investigational, proprietary topical formulation of the chemotherapeutic agent mechlorethamine (previously approved as an intravenous formulation) in development for the treatment of early stage (stages I-IIA) mycosis fungoides, a type of Cutaneous T-Cell Lymphoma (CTCL).

LDMP (paroxetine mesylate)

Company: Noven Pharmaceuticals, Inc.
Treatment for: Postmenopausal Symptoms

LDMP (paroxetine mesylate) is a low-dose non-hormonal therapy in development for the treatment of vasomotor symptoms associated with menopause.

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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