Printer Friendly
The Free Library
19,595,263 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

CDER CYBER LETTERS.


The following untitled letters were e-mailed by the Office of Compliance at the Center for Drugs to firms that sell dietary supplements and/or prescription drugs prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug,  from Web sites. Copies of these letters are available from our RECORD-RETRIEVE Service for $7 plus retrieval.

10519W

#1 Drugstore Online, Singapore, April 24 (CDER-OC). 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.
 cited the firm for promoting the sale of Tramol (tramadol HCL tramadol HCl (tram´dol),
n brand name: Ultram;
drug class: synthetic opioid analgesic;
action:
) and Stanolol (stanozolol) because the agency could not assure consumers the drugs were made in accordance with U.S. specifications. The letter also noted that "federal law prohibits the sale of prescription drugs to U.S. citizens without a valid prescription. Web

10520W

SamjinPharm, Seoul, Korea, April 24 (CDER-OC). The letter deemed the company's Web site, which was allegedly promoting sales of naloxone HCL naloxone HCl (nalok´sōn),
n brand name: Narcan;
drug class: narcotic antagonist;
action: competes with narcotics at narcotic receptor sites;
uses:
 and "Samjin lidocaine lidocaine /li·do·caine/ (li´do-kan) an anesthetic with sedative, analgesic, and cardiac depressant properties, applied topically in the form of the base or hydrochloride salt as a local anesthetic; also used in the latter form as a ," violative because of availability to U.S citizens without a prescription and because the agency could not assure the products were made to U.S. standards. Web
COPYRIGHT 2001 Washington Information Source, Inc.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001 Gale, Cengage Learning. All rights reserved.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Warning Letter Bulletin
Date:Jul 2, 2001
Words:157
Previous Article:DDMAC UNTITLED LETTERS.
Next Article:MEDICAL DEVICES.



Related Articles
CDER CYBER LETTERS.
CDER CYBER LETTERS.
CDER CYBER LETTERS.
CDER CYBER LETTERS.
CDER CYBER LETTERS.
CDER CYBER LETTERS.
CDER CYBER LETTERS.
CDER CYBER LETTERS.
CDER CYBER LETTERS.
CDER cyber letters.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles