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.
tivozanib
Company: AVEO Oncology and Astellas Pharma Inc.
Treatment for: Renal Cell Carcinoma
Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor in development for the treatment of advanced renal cell carcinoma.
- AVEO and Astellas Report FDA Oncologic Drug Advisory Committee Votes Tivozanib Application Did Not Demonstrate Favorable Benefit-to-Risk Evaluation in Treatment of Advanced Renal Cell Carcinoma - May 2, 2013
- AVEO and Astellas Announce FDA Advisory Committee To Review Tivozanib for the Treatment of Advanced Renal Cell Carcinoma - February 27, 2013
- AVEO and Astellas Announce FDA Acceptance of NDA Filing for Tivozanib for the Treatment of Advanced Renal Cell Carcinoma - November 28, 2012
- AVEO and Astellas Announce Submission of New Drug Application for Tivozanib for the Treatment of Advanced Renal Cell Carcinoma - September 28, 2012
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.
- Titan Pharmaceuticals Receives Complete Response Letter From the FDA for Probuphine New Drug Application - May 1, 2013
- Titan Pharmaceuticals Announces Date of FDA Advisory Committee Review of Probuphine for the Treatment of Opioid Dependence - February 27, 2013
- Titan Pharmaceuticals Announces Submission of New Drug Application for Probuphine for the Treatment of Opioid Dependence - October 29, 2012
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).
- FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD) - May 10, 2013
- FDA Advisory Committee Recommends Approval of Breo Ellipta for the Treatment of COPD - April 17, 2013
- GSK and Theravance Announce FDA Acceptance of FF/VI New Drug Application (NDA) Submission in the US for COPD - September 26, 2012
Levadex (dihydroergotamine) Oral Inhalation
Company: MAP Pharmaceuticals, Inc.
Treatment for: Migraine
Levadex (dihydroergotamine) is an investigational orally inhaled migraine therapy.
- Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Levadex (dihydroergotamine) New Drug Application - April 16, 2013
- MAP Pharmaceuticals Resubmits New Drug Application to FDA for Levadex Orally Inhaled Migraine Drug - October 16, 2012
- MAP Pharmaceuticals Provides Update Following Meeting with FDA for Levadex (dihydroergotamine) New Drug Application - June 25, 2012
- MAP Pharmaceuticals Provides Update on Levadex Program - April 12, 2012
- MAP Pharmaceuticals Receives Complete Response Letter from FDA for Levadex (dihydroergotamine) NDA - March 26, 2012
- MAP Pharmaceuticals Issued U.S. Patent for Methods of Achieving Rapid Relief of Migraine and Minimizing Side Effects Based Upon Pharmacokinetic Profile - August 11, 2011
- MAP Pharmaceuticals Announces FDA Acceptance for Filing of NDA for Levadex - August 2, 2011
- MAP Pharmaceuticals Submits New Drug Application to FDA for Levadex Orally Inhaled Migraine Drug - May 27, 2011
- MAP Pharmaceuticals Announces FDA Will Not Require a Second Pivotal Efficacy Study for Levadex NDA Submission - January 11, 2010
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.
- Bayer's Investigational Riociguat Granted U.S. FDA Priority Review for Pulmonary Arterial Hypertension and Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension - April 8, 2013
- Bayer Submits New Drug Application for Riociguat for the Treatment of Pulmonary Arterial Hypertension and Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension - February 12, 2013
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.
- FDA Rejects A.P. Pharma's Cancer Drug - April 2, 2013
- A.P. Pharma Receives FDA Complete Response Letter for APF530 - March 29, 2013
- A.P. Pharma Announces PDUFA Action Date for APF530 New Drug Application Resubmission - October 16, 2012
- A.P. Pharma Provides Regulatory Update on APF530 NDA - April 25, 2011
- A.P. Pharma Receives FDA Complete Response Letter for APF530 - March 19, 2010
- A.P. Pharma Announces FDA Acceptance of APF530 New Drug Application for Chemotherapy-Induced Nausea and Vomiting - July 20, 2009
- A.P. Pharma Submits New Drug Application for APF530 in Chemotherapy-Induced Nausea and Vomiting - May 18, 2009
Iluvien (fluocinolone acetonide)
Company: pSivida Corp.
Treatment for: Macular Edema
Iluvien (fluocinolone acetonide) is an intravitreal implant in development for the treatment of diabetic macular edema.
- pSivida Reports on Resubmission to FDA of NDA for Iluvien for Chronic Diabetic Macular Edema - April 2, 2013
- pSivida Reports Updates on Iluvien for Planned Resubmission to FDA and European Launch - March 22, 2013
- pSivida Corp. Reports Alimera's Intention to Resubmit Application to FDA for Iluvien in DME Using Data from Completed Trials - August 1, 2012
- pSivida Reports Receipt by Alimera Sciences of Complete Response Letter from FDA for Iluvien for DME - November 11, 2011
- pSivida Announces Resubmission of New Drug Application for Iluvien - May 13, 2011
- FDA Issues Complete Response Letter Regarding New Drug Application for Iluvien - December 26, 2010
- pSivida Announces Iluvien Receives FDA Priority Review for Treatment of Diabetic Macular Edema - August 31, 2010
- pSivida Announces Submission of NDA to FDA for an Ophthalmic Product for Diabetic Macular Edema - June 29, 2010
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.
- Boehringer Ingelheim, Lilly Submit NDA for Empagliflozin - March 29, 2013
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.
- FDA Sets 26 August 2013 As New PDUFA Date For MoxDuo NDA - March 14, 2013
- QRxPharma Resubmits MoxDuo New Drug Application to the FDA - February 28, 2013
- QRxPharma and FDA Establish Path Forward for Resubmission Of Moxduo New Drug Application - January 16, 2013
- QRxPharma Receives Complete Response Letter From FDA Regarding MoxDuo NDA - June 27, 2012
- QRxPharma Granted Target Date for FDA Action on MoxDuo IR NDA: NDA Accepted for Review; PDUFA Date Set for June 25, 2012 - November 11, 2011
- QRxPharma Completes NDA Submission for MoxDuo IR - August 26, 2011
- QRxPharma Announces NDA Filing for MoxDuo IR - July 19, 2011
Stedesa (eslicarbazepine acetate)
Company: Sepracor Inc.
Treatment for: Epilepsy, Seizures
Stedesa (eslicarbazepine acetate) is a voltage-gated sodium channel blocker in development as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.
- Sunovion Announces FDA Acceptance for Review of New Drug Application Resubmission for Stedesa (eslicarbazepine acetate) as a Once-Daily Adjunctive Therapy for Partial-onset Seizures in Adults with Epilepsy - March 8, 2013
- FDA Provides Complete Response to Sepracor's New Drug Application for Stedesa - May 4, 2010
- FDA Extends PDUFA Action Date for Stedesa New Drug Application - January 29, 2010
- Sepracor's Stedesa (eslicarbazepine acetate) New Drug Application Formally Accepted for Review by the FDA - June 1, 2009
- Sepracor Announces Submission of Stedesa New Drug Application to FDA for Adjunctive Treatment of Epilepsy - March 31, 2009
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).
- Ceptaris Resubmits New Drug Application (NDA) to FDA for Proprietary Gel Formulation of Mechlorethamine Hydrochloride - March 8, 2013
- FDA Accepts Filing of New Drug Application (NDA) for Yaupon's Proprietary Gel Formulation of Mechlorethamine Hydrochloride - October 4, 2011
- Yaupon Therapeutics, Inc. Submits New Drug Application for Proprietary Gel Formulation of Mechlorethamine Hydrochloride - July 28, 2011
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.
- Noven Announces FDA Advisory Committee Vote on Investigational Low-Dose Mesylate Salt of Paroxetine (LDMP) for Vasomotor Symptoms Associated with Menopause - March 6, 2013
- FDA Accepts Noven's NDA For An Investigational Nonhormonal Therapy For Menopausal Vasomotor Symptoms - November 14, 2012
- Noven Submits New Drug Application for Investigational Non-Hormonal Therapy for Menopausal Vasomotor Symptoms - August 29, 2012
See also: Generic Approvals, New Drug Approvals, Recent Additions to Drugs.com, Alphabetical Listing of all New Drug Applications, FDA Approval Process
