Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

FDA Prompts Removal of Unapproved Drugs From Market

March 2, 2011 By Bio-Medicine.Org

SILVER SPRING, Md., March 2, 2011 /PRNewswire-USNewswire/ — The
U.S. Food and Drug Administration today took action against
companies that manufacture, distribute, or market certain
unapproved prescription oral cough, cold, and allergy products. The
affected products cannot be legally marketed in the United
States.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Unapproved prescription cough, cold, and allergy drug products
have not been evaluated by the FDA for safety, effectiveness, and
quality. People may be at greater risk when using these products
than when using FDA-approved prescription drugs or drugs that are
appropriately marketed over-the-counter (OTC).  

Many health care providers are unaware of the unapproved status
of drugs and have continued to unknowingly prescribe them because
the drugs’ labels do not disclose that they lack FDA approval.

“Removing these unapproved products from the market will reduce
potential risks to consumers,” said Deborah Autor, director of the
Office of Compliance in the FDA’s Center for Drug Evaluation and
Research.  “There are many FDA-approved prescription products,
as well as appropriately marketed over-the-counter products,
available to treat cough, cold, and allergy symptoms; so, we expect
little or no negative impact on consumers from the removal of these
unapproved products.”  

Companies that have previously listed products subject to
today’s action with FDA are expected to stop manufacturing them
within 90 days and stop shipping the products within 180 days.
 Companies that have not previously listed products subject to
today’s action with FDA are expected to stop manufacturing and
shipping their products immediately.

Given that so many cough, cold, and allergy drug products exist
that are FDA-approved prescription products or are appropriately
marketed OTC, taking an unapprov

‘/>”/>

SOURCE

Related Articles Read More >

A photo of Capstan Medical's mitral valve implant, which uses nitinol.
Capstan Medical’s R&D head discusses the heart valve and robotics startup’s tech, engineering challenges and solutions, advice for others in medtech and how to join his team
An illustration of a neurosurgeon using a robotic endoscope to remove a brain tumor.
MDO Nitinol Innovation Special Report
A photo of Highridge Medical CEO Rebecca Whitney.
Highridge Medical is betting on this spine tech
A photo of the miniature Auxilium Biotechnologies implants made on the International Space Station.
Implants 3D-printed in space could enable nerve regeneration
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe