X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

  • 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

Aquestive Therapeutics Receives FDA Approval for Exservan Oral Film

Content Team by Content Team
26th November 2019
in FDA Approvals, Press Statements
Aquestive Therapeutics Receives FDA Approval for Exservan Oral Film

Aquestive Therapeutics, a specialty pharmaceutical company focused on developing and commercializing differentiated products to solve therapeutic problems, announced that Exservan Oral Film received early-action approval from the U.S. FDA for the treatment of amyotrophic lateral sclerosis (ALS), an orphan disease.

“We received full FDA approval for Exservan in advance of our PDUFA action date. We appreciate the ongoing feedback from the FDA and its early-action approval. We anticipate that Exservan, via our orally administered PharmFilm® dosage form, will bring meaningful treatment to patients who are diagnosed with ALS and face difficulties swallowing or administering traditional forms of medication,” said Keith J. Kendall, Chief Executive Officer of Aquestive. “In line with our stated objectives, we licensed this product to Zambon S.p.A. for development and commercialization in the EU. We are continuing the dialogue with potential licensees for the US commercial rights.”

Exservan (riluzole) Oral Film is now approved for the treatment of ALS, a debilitating and rare disease affecting as many as 30,000 Americans1 and 52,000 Europeans2. Exservan will now fill a critical need in the armamentarium for ALS patients because it can be administered safely and easily, twice daily, without water where many patients have trouble swallowing. Development initiatives conducted by Aquestive have included studies demonstrating Exservan’s pharmacokinetic bioequivalence to the reference listed drug, Rilutek®, as well as additional studies to assess patients’ ability to swallow Exservan. Exservan received FDA orphan drug designation in January 2018.

About Aquestive Therapeutics
Aquestive Therapeutics is a specialty pharmaceutical company that applies innovative technology to solve therapeutic problems and improve medicines for patients. Aquestive is advancing a late-stage proprietary product pipeline to treat CNS conditions and provide alternatives to invasively administered standard of care therapies. The Company also collaborates with other pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven capabilities for drug development and commercialization.

Previous Post

Med-Tech Innovation Expo and Medilink UK renew partnership

Next Post

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

Related Posts

ACHEMA 2022 addresses the industry's key issues digitalisation and sustainability
Manufacturing

ACHEMA 2022 addresses the industry’s key issues digitalisation and sustainability

14th June 2022
development of new antibiotics
Drug Development

EMA guidance supports development of new antibiotics

30th May 2022
Vienna Airport and Lufthansa Cargo launch pharma cooperation
Packaging & Logistic

Vienna Airport and Lufthansa Cargo launch pharma cooperation

10th May 2022
Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities
Drug Development

Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

6th May 2022
Catalent Expands Nasal Drug Development and Manufacturing Capabilities at Morrisville, North Carolina, Facility
Press Statements

Catalent Expands Nasal Drug Development and Manufacturing Capabilities at Morrisville, North Carolina, Facility

6th May 2022
AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint
Drug Development

AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

6th May 2022
Next Post
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

Latest News

FDA Experts Recommend Changing COVID Jab Formulation In Fall
Manufacturing

FDA Experts Recommend Changing COVID Jab Formulation In Fall

30th June 2022
Novartis to acquire The Medicines Company for USD 9.7 bn
Manufacturing

Novartis To Slash 8,000 Jobs To Save $1 Billion By 2024

30th June 2022
How Lag In African COVID-19 Jabs Slowed Its Once Rapid Pace
Manufacturing

How Lag In African COVID-19 Jabs Slowed Its Once Rapid Pace

27th June 2022
Australia Creates A Novel Stem Cell Production Technique
Manufacturing

Australia Creates A Novel Stem Cell Production Technique

27th June 2022
Novartis to acquire The Medicines Company for USD 9.7 bn
Manufacturing

Novartis Promises $250M For Tropical Illnesses, Malaria

27th June 2022
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