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 warns against purchasing Accutane online

Executive Summary

FDA launches a Web site March 28 to warn consumers about the dangers of purchasing the acne medication isotretinoin (Roche's Accutane and generics) online. The agency advises, "Buying this product over the Internet bypasses important procedures to ensure that patients can take this drug safely," and may result in patients receiving counterfeit products. Isotretinoin is legally available only through iPLEDGE, a restricted distribution and risk management system to ensure the drug is not prescribed to pregnant patients. However, implementation of the iPLEDGE program has been plagued with compliance issues (1"The Pink Sheet" Sept. 4, 2006, p.15)...

You may also be interested in...



Accutane iPLEDGE Program Glitches Continue Six Months After Launch – AADA

Implementation problems with the iPLEDGE pregnancy risk management program for the acne therapy isotretinoin (Roche's Accutane and generics) may be relieved by eliminating the mandatory one month hiatus between physician office visits, a study by the American Academy of Dermatology Association found

Roche/Genentech Keeps Commitment To External Cancer Innovation

Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.

US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials

To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.

UsernamePublicRestriction

Register

OM009724

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