Accessing FDA approval packages and briefing documents [1]

Annals of Pharmacotherapy

Volumn 41, Issue 12, 2007, Pages 2071-2072

  Ohmer, Joseph ^a   Miller, Jeffrey W ^a   Sasich, Larry D ^a  

^a LAKE ERIE COLLEGE OF OSTEOPATHIC MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; MURAGLITAZAR; TELITHROMYCIN;

CONGESTIVE HEART FAILURE; DEATH; DRUG APPROVAL; DRUG EFFICACY; DRUG FORMULARY; DRUG LABELING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; HUMAN; LETTER; LIVER TOXICITY; MEDICAL LITERATURE; MEDICAL PERSONNEL; PEER REVIEW; PRIORITY JOURNAL; PUBLICATION; QT PROLONGATION; SIDE EFFECT; TREATMENT RESPONSE; UNITED STATES; VISUAL DISORDER;

DOCUMENTATION; DRUG APPROVAL; GLYCINE; KETOLIDES; OXAZOLES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 36849001734     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1K268     Document Type: Letter

References (5)

1. Graham DJ. Telithromycin and acute liver failure. N Engl J Med 2006;355:21:2260-1.
2. FDA drug approval package: Ketek (telithromycin), 2004. www.fda.gov/cder/foi/nda/2004/21-144_Ketek.htm. (accessed 2007 Apr 15).
3. Brophy JM. Selling safety: lessons from muraglitazar. JAMA 2005;294:2633-5.
4. Nissen SE, Wolski K, Topol EJ. Effect of muraglitazar on death and major adverse cardiovascular events in patients with type 2 diabetes mellitus. JAMA 2005;294:2581-6.
5. FDA advisory committee briefing document: Pargluva (muraglitazar, BMS-298585), 2005. www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B2_02_00- FDATOC.htm (accessed 2007 May 9).