X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Dicerna, Novo Nordisk sign RNAi deal for liver-related cardio-metabolic diseases

    Dicerna, Novo Nordisk sign RNAi deal for liver-related cardio-metabolic diseases

    Elsevier and FDA to work on AI algorithm for drug-induced liver injury

    Elsevier and FDA to work on AI algorithm for drug-induced liver injury

    Aquestive Therapeutics Receives FDA Approval for Exservan Oral Film

    Aquestive Therapeutics Receives FDA Approval for Exservan Oral Film

    Med-Tech Innovation Expo and Medilink UK renew partnership

    Med-Tech Innovation Expo and Medilink UK renew partnership

    Inceptua and Bendalis enter into an exclusive oncology medicine supply agreement for clinical trials

    Inceptua and Bendalis enter into an exclusive oncology medicine supply agreement for clinical trials

    Generic Version of Medrol

    Oakrum Pharma and SunGen Pharma Announce U.S. Launch of Generic Version of Medrol

    Fig extract for healthy blood sugar levels

    Fig extract for healthy blood sugar levels

    Novartis ligelizumab outperforms Roche’s Xolair in chronic urticaria clearance

    Amgen declares positive results for 2 Phase 3 BLINCYTO studies

    Amgen declares positive results for 2 Phase 3 BLINCYTO studies

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Dicerna, Novo Nordisk sign RNAi deal for liver-related cardio-metabolic diseases

    Dicerna, Novo Nordisk sign RNAi deal for liver-related cardio-metabolic diseases

    Elsevier and FDA to work on AI algorithm for drug-induced liver injury

    Elsevier and FDA to work on AI algorithm for drug-induced liver injury

    Aquestive Therapeutics Receives FDA Approval for Exservan Oral Film

    Aquestive Therapeutics Receives FDA Approval for Exservan Oral Film

    Med-Tech Innovation Expo and Medilink UK renew partnership

    Med-Tech Innovation Expo and Medilink UK renew partnership

    Inceptua and Bendalis enter into an exclusive oncology medicine supply agreement for clinical trials

    Inceptua and Bendalis enter into an exclusive oncology medicine supply agreement for clinical trials

    Generic Version of Medrol

    Oakrum Pharma and SunGen Pharma Announce U.S. Launch of Generic Version of Medrol

    Fig extract for healthy blood sugar levels

    Fig extract for healthy blood sugar levels

    Novartis ligelizumab outperforms Roche’s Xolair in chronic urticaria clearance

    Amgen declares positive results for 2 Phase 3 BLINCYTO studies

    Amgen declares positive results for 2 Phase 3 BLINCYTO studies

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development FDA Approvals

Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-105

Content Team by Content Team
9th August 2019
in FDA Approvals, Press Statements
Eton Pharmaceuticals New Drug Application for ET-105

Eton Pharmaceuticals, Inc, a specialty pharmaceutical company focused on developing and commercializing innovative drug products, announced that Aucta Pharmaceuticals’ New Drug Application for ET-105, an innovative formulation of lamotrigine which Eton acquired the U.S. marketing rights to in June 2019, has been accepted for review by the U.S. FDA. The FDA has assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of March 17, 2020.

“The NDA acceptance of ET-105 marks an important milestone for Eton as this strengthens our growing pipeline of near-launch products. We are very excited about the potential for ET-105 to address a significant unmet need in this large and growing market,” said Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals. “Our team looks forward to working with Aucta and the FDA over the coming months as we prepare for a potential commercial launch in the first half of 2020.”

ET-105 is a patent-pending formulation of lamotrigine, for which Aucta is seeking approval as an adjunct therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients two years of age and older. Lamotrigine is one of the most widely used anti-epilepsy medications in the U.S. with sales exceeding $700 million and 1 billion tablets annually but is only FDA-approved in tablet formulations. ET-105’s innovative formula will be delivered to patients as an oral liquid and has been developed specifically to address the significant unmet need in patients with dysphagia and pediatric patients requiring precision dosing at levels below the currently available tablet strengths.

About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative products utilizing the FDA’s 505(b)(2) regulatory pathway. Eton is primarily focused on liquid dosage forms including injectables, oral liquids and ophthalmics. Eton has a diversified pipeline of high-value product candidates in various stages of development and therapeutic areas, including multiple product candidates currently pending regulatory approval with the FDA.

Previous Post

Aevi Genomic Medicine Enters into License Agreement with AstraZeneca for Anti-IL-18 Antibody

Next Post

Aucta Pharmaceuticals Announces Licensing of Vigabatrin for Oral Solution in China

Related Posts

Pharmapack announce key themes for Pharmapack Europe 2020
Middle East and South Asia

Pharmapack announce key themes for Pharmapack Europe 2020

4th December 2019
CPhI Worldwide pointing 2020 to be a strong year for pharma
Middle East and South Asia

CPhI Worldwide pointing 2020 to be a strong year for pharma

3rd December 2019
Elsevier and FDA to work on AI algorithm for drug-induced liver injury
Americas

Elsevier and FDA to work on AI algorithm for drug-induced liver injury

26th November 2019
Aquestive Therapeutics Receives FDA Approval for Exservan Oral Film
FDA Approvals

Aquestive Therapeutics Receives FDA Approval for Exservan Oral Film

26th November 2019
Med-Tech Innovation Expo and Medilink UK renew partnership
Drug Development

Med-Tech Innovation Expo and Medilink UK renew partnership

26th November 2019
Inceptua and Bendalis enter into an exclusive oncology medicine supply agreement for clinical trials
Clinical Trials

Inceptua and Bendalis enter into an exclusive oncology medicine supply agreement for clinical trials

26th November 2019
Next Post
Aucta Pharmaceuticals  Licensing of Vigabatrin for Oral Solution in China

Aucta Pharmaceuticals Announces Licensing of Vigabatrin for Oral Solution in China

Latest News

Pharmapack announce key themes for Pharmapack Europe 2020
Middle East and South Asia

Pharmapack announce key themes for Pharmapack Europe 2020

4th December 2019
CPhI Worldwide pointing 2020 to be a strong year for pharma
Middle East and South Asia

CPhI Worldwide pointing 2020 to be a strong year for pharma

3rd December 2019
Dicerna, Novo Nordisk sign RNAi deal for liver-related cardio-metabolic diseases
Drug Development

Dicerna, Novo Nordisk sign RNAi deal for liver-related cardio-metabolic diseases

26th November 2019
Elsevier and FDA to work on AI algorithm for drug-induced liver injury
Americas

Elsevier and FDA to work on AI algorithm for drug-induced liver injury

26th November 2019
Aquestive Therapeutics Receives FDA Approval for Exservan Oral Film
FDA Approvals

Aquestive Therapeutics Receives FDA Approval for Exservan Oral Film

26th November 2019
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In