Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA adopts interim plan to avoid shortage of medically necessary opioid

Executive Summary

FDA is allowing seven manufacturers and distributors of unapproved high concentration oral morphine sulfate to continue production in an effort to avoid a shortage of the medically necessary opioid. Last month FDA took action against a number of unapproved prescription opioids, asking them to cease their operations. Now the agency is amending this request and will allow 20 mg/mL morphine sulfate oral solution to be produced on an interim basis as a result of concerns from patients and health care professionals in the palliative care community; the agency was swayed by feedback that the discontinuation of the drug would cause a shortage of the opioid that is widely used to alleviate pain in terminally-ill patients. CDER is encouraging drug companies to submit applications for the opioid so it can be approved, noting that it's a "very high-priority product for the agency" and "if a product comes to us, we are going to devote whatever resources we have to make that review efficient, timely and successful.

You may also be interested in...



Pink Sheet Podcast: Woodcock To Be Acting US FDA Chief, Key Staff Depart, Political Donations Shift

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

Liquid Biopsy Company Delfi Diagnostics Raised $100M For New Class of Early Cancer Detection Test

Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials. 

Biotin And ‘Healthy Hair’: Federal Pre-emption Clips False Advertising Complaint In California

US Ninth Circuit affirms a district court’s summary judgment in favor of Target and manufacturer of Up & Up brand biotin supplement it sells. Indian manufacturer targeted in putative class-action in New York prompted FDA’s 2016 creation of import alert category for Ayurvedic supplements.

Topics

UsernamePublicRestriction

Register

LL1134025

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel