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.

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 patch in development as a form of birth control. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch.

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.

Lipocine Announces Tlando NDA PDUFA Action Date of November 9, 2019 - May 14, 2019
Lipocine Receives Complete Response Letter for Tlando From U.S. Food and Drug Administration - May 9, 2018
Lipocine Announces Outcome of FDA Advisory Committee Meeting for Tlando, Testosterone Replacement Therapy in Adult Males with Hypogonadism - January 10, 2018
Lipocine Announces FDA Acknowledgement of Tlando (LPCN 1021) NDA Resubmission - August 14, 2017
Lipocine Resubmits NDA for Its Oral Testosterone Product Candidate, LPCN 1021, for Treatment of Hypogonadism - August 9, 2017
Lipocine Receives Complete Response Letter (CRL) for LPCN 1021 From U.S. FDA - June 29, 2016
Lipocine Announces PDUFA Goal Date for LPCN 1021 NDA - November 12, 2015
FDA Accepts for Filing Lipocine's NDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021 - October 29, 2015
Lipocine Submits NDA to FDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021 - August 31, 2015

Talicia (amoxicillin, omeprazole and rifabutin) Capsules

Company: RedHill Biopharma Ltd.
Treatment for: Helicobacter pylori Infection

Talicia (RHB-105) is a fixed-dose oral combination of rifabutin and amoxicillin (both antibiotics), and omeprazole (a proton pump inhibitor (PPI)), in development for the treatment of Helicobacter pylori infection.

RedHill Biopharma Submits New Drug Application for Talicia for H. pylori Infection - May 7, 2019

Zygel (cannabidiol) Gel

Company: Zynerba Pharmaceuticals, Inc.
Treatment for: Behavioral Symptoms associated with Fragile X Syndrome

Zygel (cannabidiol gel) is a transdermal gel formulation of cannabidiol (CBD) in development for the treatment of behavioral symptoms associated with Fragile X Syndrome (FXS).

Zynerba Pharmaceuticals Receives Fast Track Designation for Zygel for the Treatment of Behavioral Symptoms Associated with Fragile X Syndrome (FXS) - May 6, 2019

bempedoic acid

Company: Esperion Therapeutics, Inc.
Treatment for: Hypercholesterolemia

Bempedoic acid is a first-in-class, ATP Citrate Lyase (ACL) inhibitor in development for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C).

Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review - May 5, 2019

Barhemsys (amisulpride) Injection - formerly Baremsis

Company: Acacia Pharma
Treatment for: Nausea/Vomiting -- Postoperative

Barhemsys (amisulpride) is a dopamine antagonist in development for the management of post-operative nausea & vomiting (PONV).

Complete Response Letter from FDA for Barhemsys - May 3, 2019
New Barhemsys PDUFA Date Confirmed for 5 May 2019 - December 7, 2018
Acacia Pharma Resubmits Barhemsys New Drug Application - November 6, 2018
FDA Issues a Complete Response Letter to Acacia Pharma for Barhemsys - October 8, 2018
Acacia Pharma Announces FDA Acceptance of NDA Filing For Baremsis for the Management of Post-Operative Nausea & Vomiting - January 4, 2018

HTX-011 (bupivacaine and meloxicam)

Company: Heron Therapeutics, Inc.
Treatment for: Postoperative Pain

HTX-011 (bupivacaine and meloxicam) is an investigational fixed-dose combination of the local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam in development for the management of postoperative pain.

Heron Therapeutics Receives Complete Response Letter For HTX-011 For The Management Of Postoperative Pain - May 1, 2019
FDA Grants Priority Review Designation for Heron Therapeutics' NDA for HTX-011, a Non-Opioid for Postoperative Pain Management - December 31, 2018
Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management - October 31, 2018

Contepo (fosfomycin)

Company: Nabriva Therapeutics plc
Treatment for: Urinary Tract Infection

Contepo (fosfomycin for injection) is an investigational epoxide antibiotic in development as a first-line treatment for complicated urinary tract infections (cUTIs), including acute pyelonephritis.

darolutamide

Company: Bayer
Treatment for: Prostate Cancer

Darolutamide is an investigational, non-steroidal androgen receptor antagonist in development for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).

cabotegravir and rilpivirine

Company: Janssen Pharmaceuticals, Inc.
Treatment for: HIV Infection

Rilpivirine and cabotegravir is a once-monthly, injectable, two-drug regimen of long-acting rilpivirine (approved in tablet form as Edurant) and the investigational integrase inhibitor cabotegravir, in development for the treatment of HIV in adults.

Janssen Announces Submission of New Drug Application to U.S. FDA For the First Monthly, Injectable, Two-Drug Regimen of Rilpivirine and Cabotegravir for Treatment of HIV - April 29, 2019

brolucizumab

Company: Novartis
Treatment for: Macular Degeneration

Brolucizumab (RTH258) is an anti-vascular endothelial growth factor (VEGF) single-chain antibody fragment in development for the treatment of wet age-related macular degeneration (AMD).

Novartis Announces FDA Filing Acceptance and Priority Review of Brolucizumab (RTH258) for Patients with Wet AMD - April 15, 2019

remimazolam

Company: Cosmo Pharmaceuticals NV
Treatment for: Anesthesia

Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic in development for use during gastrointestinal procedures.

Cosmo Pharmaceuticals Announces Submission of Remimazolam NDA to FDA - April 9, 2019

Fintepla (fenfluramine)

Company: Zogenix, Inc.
Treatment for: Dravet Syndrome

Fintepla ((ZX008, low-dose fenfluramine) is an amphetamine derivative in development for the treatment of seizures associated with Dravet syndrome.

luspatercept

Company: Celgene Corporation

Luspatercept is a first-in-class erythroid maturation agent (EMA) in development for the treatment of myelodysplastic syndromes (MDS)-associated anemia and beta-thalassemia-associated anemia.

Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA - April 5, 2019

KW-6002 (istradefylline)

Company: Kyowa Kirin, Inc.
Treatment for: Parkinson's Disease

Istradefylline (KW-6002) is an investigational adenosine A_2A receptor antagonist intended for for use as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “OFF” episodes.

Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resubmission in the US - April 4, 2019
Kyowa Hakko Receives Not Approvable Letter from FDA for Istradefylline (KW-6002) - February 28, 2008
Submission of NDA for Istradefylline (KW-6002), anInvestigational Anti-Parkinson's Disease Drug - April 27, 2007

Gimoti (metoclopramide) Nasal Spray

Company: Evoke Pharma, Inc.
Treatment for: Gastroparesis

Gimoti (metoclopramide) is an intranasal formulation of the approved drug metoclopramide in development for the treatment of symptoms associated with diabetic gastroparesis in women.

Evoke Pharma Receives Complete Response Letter and Recommendations to Address Deficiencies from FDA for Gimoti NDA - April 2, 2019
Evoke Pharma Submits Response to FDA Review Letter for Gimoti NDA - March 14, 2019
Evoke Pharma’s Gimoti NDA Accepted for FDA Review - August 16, 2018
Evoke Announces FDA Submission of New Drug Application for Gimoti - June 4, 2018
FDA Approves PDUFA Fee Waiver for Gimoti New Drug Application - March 5, 2018

ozanimod

Company: Celgene Corporation
Treatment for: Multiple Sclerosis, Ulcerative Colitis

Ozanimod is an investigational selective sphingosine 1-phosphate (S1P) 1 and 5 receptor modulator in development for the treatment of patients with relapsing multiple sclerosis, and ulcerative colitis.

Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis - March 25, 2019

Zynquista (sotagliflozin)

Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Diabetes Type 1

Zynquista (sotagliflozin) is an investigational dual SGLT1 and SGLT2 inhibitor for use in combination with insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.

FDA Issues Complete Response Letter for Zynquista (sotagliflozin) - March 25, 2019
FDA Advisory Committee Votes on Zynquista (sotagliflozin) as Treatment for Adults with Type 1 Diabetes - January 17, 2019
FDA to Review Zynquista (sotagliflozin) as Potential Treatment for Type 1 Diabetes - May 22, 2018
Lexicon Pharmaceuticals Announces Regulatory Submissions for Sotagliflozin to Treat Adults with Type 1 Diabetes - March 26, 2018

selinexor

Company: Karyopharm Therapeutics Inc.
Treatment for: Multiple Myeloma

Selinexor (KPT-330) is a first in class Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist in development for the treatment of patients with penta-refractory multiple myeloma.

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