FDA approves Prior Approval Supplement for EMBEDA Extended Release Capsules CII

Download PDF Copy

Nov 4 2013

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved a Prior Approval Supplement for EMBEDA^® (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII.

The Prior Approval Supplement included an update to the EMBEDA manufacturing process that addressed the pre-specified stability requirement that led to the voluntary recall of EMBEDA from the market in March 2011. Pfizer anticipates product availability in the second quarter of 2014.

Source:

Pfizer Inc.

Posted in: Pharmaceutical News

Tags: Acute Pancreatitis, Addiction, Analgesia, Anaphylaxis, Anesthetics, Anxiety, Asthma, Blood Pressure, Chronic Obstructive Pulmonary Disease, Chronic Pain, Constipation, Consumer Health, Depression, Depressive Disorder, Drugs, Food, Head Injury, Health Care, Healthcare, Hormone, Hypersensitivity, Hypotension, Hypoxia, Ileus, Major Depressive Disorder, Manufacturing, Morphine, Muscle, Naltrexone, Nausea, Nervous System, Opioids, Pain, Pancreatitis, Pharmacokinetics, Respiratory, Seizure

Comments (0)

Download PDF Copy

Suggested Reading

Omalizumab boosts tolerance to multiple food allergies, study finds

Omalizumab boosts tolerance to multiple food allergies, study finds

Ultra-processed foods raise chronic kidney disease risk, study shows

Ultra-processed foods raise chronic kidney disease risk, study shows

Study links ultra-processed food consumption with higher cardiovascular risk

Study links ultra-processed food consumption with higher cardiovascular risk

Maternal influences on food allergy prevention: A closer look at diet and environment

Maternal influences on food allergy prevention: A closer look at diet and environment

Feeling lonely? It may affect how your brain reacts to food, new research suggests

Feeling lonely? It may affect how your brain reacts to food, new research suggests

Study exposes food insecurity among graduate students and postdocs

Study exposes food insecurity among graduate students and postdocs

New research sheds light on how GLP-1 obesity drugs may change food cravings

New research sheds light on how GLP-1 obesity drugs may change food cravings

Can you spot the difference? Study explores the appeal of AI-generated vs. real food images

Can you spot the difference? Study explores the appeal of AI-generated vs. real food images

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

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...

Study reveals daily food environment exposure shapes fast food habits