Eisai announces FDA acceptance of AcipHex NDA for priority review

Download PDF Copy

Editorial Checklist

Reviewed

Eisai Inc.Nov 30 2012

NewsGuard 100/100 Score

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review Eisai's New Drug Application (NDA) for AcipHex® Delayed-Release Sprinkle Capsules 5mg and 10mg for the proposed indication of healing of Gastroesophageal Reflux Disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children 1 to 11 years of age.

Acceptance of the NDA indicates that the FDA has found the company's submission to be sufficiently complete to review. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of March 27, 2013.

Source:

Posted in: Child Health News | Pharmaceutical News

Tags: Abdominal Pain, Acid Reflux, Antibody, Atazanavir, Children, Clostridium Difficile, Constipation, Diarrhea, Fever, Food, Gastroesophageal Reflux Disease, Headache, Heartburn, Methotrexate, Muscle, Nausea, Neuroscience, New Drug Application, Oncology, Pain, Prescription Drug, Sore Throat, Spine, Vomiting, Warfarin

Comments (0)

Download PDF Copy

Suggested Reading

Updated Food Compass 2.0 improves food health ratings using new diet data

Updated Food Compass 2.0 improves food health ratings using new diet data

Ultra-processed foods dominate children's diets from toddlerhood to middle childhood

Ultra-processed foods dominate children's diets from toddlerhood to middle childhood

Limiting fast-food outlets can reduce childhood overweight and obesity

Limiting fast-food outlets can reduce childhood overweight and obesity

Key triggers for food allergies in children after organ transplants

Key triggers for food allergies in children after organ transplants

Six common flying with food allergies myths

Six common flying with food allergies myths

Frequent ultra-processed food consumption raises mortality risks, especially in women

Frequent ultra-processed food consumption raises mortality risks, especially in women

Ultra-processed food linked to weight gain and lower well-being in adolescents

Ultra-processed food linked to weight gain and lower well-being in adolescents

Online food shopping: Are you getting the information you need?

Online food shopping: Are you getting the information you need?

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.

Post a new comment

Post

Hi, I'm Azthena, you can trust me to find commercial scientific answers from News-Medical.net.

To start a conversation, please log into your AZoProfile account first, or create a new account.

Registered members can chat with Azthena, request quotations, download pdf's, brochures and subscribe to our related newsletter content.

A few things you need to know before we start. Please read and accept to continue.

Use of “Azthena” is subject to the terms and conditions of use as set out by OpenAI.
Content provided on any AZoNetwork sites are subject to the site Terms & Conditions and Privacy Policy.
Large Language Models can make mistakes. Consider checking important information.

I understand, and agree to receive occasional emails about Azthena such as usage tips and new feature announcements.

Please check the box above to proceed.

Great. Ask your question.

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...

Not all ultra-processed foods are made alike: Researchers warn against villainizing entire food group