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CVM UNTITLED LETTERS.


These letters are the regulatory activity letters issued by the Division of Epidemiology and Surveillance, Office of Surveillance and Compliance to makers of veterinary drugs. Copies are available from our RECORD-RETRIEVE service for $7 plus retrieval.

10553W

MS Bioscience, Madison, WI, March 14 (CVM-Division of Epidemiology and Surveillance). The agency cited MS for objectionable claims for PREEMPT pre·empt or pre-empt  
v. pre·empt·ed, pre·empt·ing, pre·empts

v.tr.
1. To appropriate, seize, or take for oneself before others. See Synonyms at appropriate.

2.
a.
 including "rapidly colonizes and establishes a healthy gut flora" and "improves the growth and production characteristics of your flock." The letter stated that the approved claim was "for the early establishment of intestinal microflora microflora /mi·cro·flo·ra/ (-flor´ah) the microscopic vegetable organisms of a special region.
Microflora
The bacterial population in the intestine.
 in chickens to reduce Salmonella colonization."

10554W

Pharmacia & Upjohn, Kalamazoo, MI, March 1 (CVM-Division of Epidemiology and Surveillance). FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 referred to a drug experience report filed for Lutalyse (dinoprost tomethamine) and noted a "continuing trend in your company's promotion of extra-label use of products in conjunction with the "100-day contract" and associated protocols. The agency insisted that treatment of bovines with abnormal calvings with the drug in conjunction with ECP (Enhanced Capabilities Port) See IEEE 1284.

1. ECP - Engineering Change Proposal.
2. ECP - Enhanced Capabilities Port.
3. ECP - Extended Capabilities Port.
4. ECP - Extended Concurrent Prolog.
  explain this to stimulate uterine cleaning was an off-label use, causing Lutalyse to be misbranded mis·brand  
tr.v. mis·brand·ed, mis·brand·ing, mis·brands
To brand or label misleadingly or fraudulently.

Adj. 1.
. Lab
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Article Details
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Publication:Warning Letter Bulletin
Date:Jul 2, 2001
Words:177
Previous Article:FOODS/DIETARY SUPPLEMENTS.
Next Article:ANIMAL DRUGS/FEED.



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