Ketek safety committee review
Executive Summary
FDA's Anti-Infective Drugs and Drug Safety & Risk Management Committees will review the benefit/risk profile of Sanofi-Aventis' antibiotic Ketek (telithromycin) during a Dec. 14-15 meeting. Labeling for Ketek was updated in June to include strengthened liver toxicity warnings (1"The Pink Sheet" July 3, 2006, p. 7). The meeting will be held at the Crowne Plaza in Silver Spring, Md., beginning at 8 a.m. both days. [Editor's note: To 2watch a webcastor order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]...
You may also be interested in...
Ketek Labeling Gets Updated Warning, But Not Format, After Liver Toxicity
Sanofi-Aventis is making a relatively modest labeling change to its antibiotic Ketek (telithromycin) following reports of hepatoxicity
Execs On The Move: Promotions At Agilent And CHF Solutions; New Chief At Zimmer
CHF Solutions adds “CEO” to its president’s job title; Agilent VP of business development promoted to senior VP; Zimmer hires chief transformation officer; and more.
Pfizer’s Pegfilgrastim Biosimilar ‘Has Launched’ In The US
Pfizer has pressed on with the launch of a fourth biosimilar pegfilgrastim product, Nyvepria (pegfilgrastim-apgf), according to an investment bank. With Amgen continuing to hold more than 70% of the market, there is opportunity for Pfizer to capture significant market share.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: