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

SERTRALINE ADVISORY COMMITTEE AGENDA REVEALS LITTLE ABOUT FDA CONCERNS

Executive Summary

The agenda of the upcoming Nov. 19 meeting of FDA's Psychopharmacologic Drugs Advisory Committee to consider recommending approval of Pfizer's antidepressant drug sertraline tells little, if any, about FDA's concerns with the drug. FDA says in the tersely worded agenda that the division of Neuropharmacological Drug Products "has reviewed the NDA submitted by Pfizer for sertraline and, before forwarding a recommendation to the Office of Drug Evaluation I...seeks the committee's advice" on two questions: Has Pfizer provided evidence from more than one clinical study that supports efficacy of the drug for depression?; and has Pfizer provided evidence of the drug's safety? The agenda is typical of FDA's Neuropharmacological Drug Products Division. The division does not identify specific approval issues in advisory committee agenda questions. Sertraline will be the second of the serotonin reuptake inhibitors for depression to make it to an FDA advisory committee review. Lilly's Prozac was the first serotonin uptake inhibitor reviewed and approved by FDA. Prozac was reviewed by an advisory committee five years ago, in October 1985. The full NDA review for the Lilly drug took four-and-a-half years. The sertraline NDA has been pending at FDA for two-and-a-half years.

You may also be interested in...



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

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth
UsernamePublicRestriction

Register

PS018336

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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