Pink Sheet is part of the Business Intelligence Division 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

THIRD GENERATION CEPHALOSPORIN LABELS NEED FDA PROPHYLAXIS COMMENT -- CMTE.

Executive Summary

The FDA should consider making labeled editorial comments as to the benefits and disadvantages of the prophylactic use of third generation cephalosporins in surgery on products getting agency approval for that indication, FDA's Anti-Infective Drugs Advisory Cmte. recommended at its Oct. 29 meeting. The cmte. was asked to answer the question: "Should third generation cephalosporins and other new drugs be permitted to have prophylaxis-in-surgery claims?" The cmte. agreed that third generation cephalosporins should be allowed to have indications for prophylactic use in surgery if those claims were supported by studies. But the cmte. suggested that FDA consider "an additional comment in the labeling as to . . . the merits, or lack thereof, of the use of third generation cephalosporins for prophylaxis." Explaining the in-house opinions on third generation prophylactic use, FDA Anti-Infective Div. Group Leader George Stanley, MD, said: "Within our division we're split 50/50 about whether third generation cephalosporins really deserve to be used as prophylactics. Stanley said that "one group feels that if the mfr. has demonstrated that the drug is safe and effective, ]there is[ an obligation to approve it because that is the policy that we've always taken and it should be left to the infectious disease community to decide whether to put these drugs on hold." There is "an equally vocal group," Stanley continued, that feels "this is probably a misuse of ]third generation[ cephalosporins and that we as an agency should take a position that they shouldn't be used this way." High costs, development of resistant bacterial strains, and lack of superior efficacy to first and second generation cephalosporins were cited as concerns with the prophylactic use of third generation cephalosporins by the cmte. While several cmte. members stated that they would not use the third generation in prophylaxis situations, the cmte. agreed that it was not its "role" to deny approval of a claim if evidence supported it.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS009199

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