Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Meridia Needs Continued Intensive Monitoring For Pediatric Adverse Events

Executive Summary

Pediatric adverse events associated with Abbott's weight-loss agent Meridia should be monitored more intensively for a second year, FDA's Pediatric Advisory Committee unanimously recommended

You may also be interested in...



Public Citizen Meridia petition denied

Abbott's Meridia (sibutramine) will remain on the market after FDA denies Public Citizen's 2002 petition to withdraw the weight-loss drug. In its Aug. 9 FDL-1response, FDA acknowledges some risks associated with Meridia but says they can be addressed by Abbott's recently revised risk management program. The agency also disputes Public Citizen's use of AERS reports to support its argument that the fatality rate associated with Meridia is enough to warrant its withdrawal. Abbott's 9,000-patient long-term safety study (SCOUT) may address the issue; as of April, 8,000 patients had been enrolled (1"The Pink Sheet" June 25, 2001, p. 13)...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Latest Headlines
See All
UsernamePublicRestriction

Register

PS047040

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