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By accessing and using this document, you are agreeing to the following terms and conditions and all applicable laws.

These documents provide information on the results of certain drug studies initiated on or after October 15, 2002 sponsored or conducted by URL Pharma or its subsidiaries or affiliates. The nature and purpose of this document is to comply with certain applicable laws and is non-promotional.

Product information provided in these documents may differ with other published data due to the limited scope of the information published here. In case of doubt, please refer to the prescribing information approved by the FDA.


No Medical Advice Included


Patients: Nothing in these documents should be construed as the giving of medical advice or the making of a recommendation. These documents should not be relied on as the basis for any decision or action or replace medical advice, medical visits or recommendations from health care providers. Any questions regarding the information in these documents should be directed to your physician.


Healthcare Providers: This is not a prescription consultation service. The information in these documents is not prescribing information, and prescribing decisions should always refer to the specific labeling information approved by the FDA.


No Representation or Warranty, No Liability


While URL Pharma uses reasonable efforts to provide accurate information in these documents, everything in these documents is provided “AS IS”. URL Pharma does not make, and expressly disclaims, any representations or warranties of any kind, either express or implied (including without limitation any implied warranties of merchantability, fitness for a particular purpose or non-infringement) with regard to any such information, its accuracy or completeness or the frequency that it is updated. URL Pharma assumes no liability or responsibility for any errors or omissions in the content of these documents and your use of this document is at your own risk. URL Pharma (including its officers, directors, employees or affiliates) shall not be liable for any damages of any kind or any claims or losses, resulting from or in connection with the creation or use of, or reliance on, this document.


Impermissible Use


These documents do not confer rights in any trademarks and service marks used in these documents, whether owned by URL Pharma or others. The results data provided in these documents are the property of URL Pharma and may not be copied, transcribed, published or otherwise used, without written permission.


Applicable Law


These terms and conditions shall be governed by and construed in accordance with the laws of the State of Pennsylvania, without regard to its choice of law principles

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FDA Unapproved Drugs Initiative

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FDA NEWS RELEASE: FDA orders halt to marketing of unapproved single-ingredient oral colchicine

 

FDA Questions and Answers for Patients and Healthcare Providers Regarding Single-ingredient Oral Colchicine Products

 

FDA calls on Pharmacists to dispense only FDA Approved drugs, see the video below:

 

 

  • FDA Drug Info Rounds: Single-Ingredient Oral Colchicine Video

 

  • Colchicine (marketed as Colcrys) Information

 

  • New Safety Information for Colchicine (marketed as Colcrys)

 

  • New Colchicine Product and Dosing Regimen

 

  • Dr. Woodcock's letter on Unapproved Colchicine 3/3/10

  • FDA Consumer Health Information article on removal of unapproved cough, cold and allergy products from the market (March 2011)

  • FDA press release on removal of unapproved oral cough, cold and allergy products from the market (March 2011)

 

  • FDA's Concerns about Unapproved Drugs

 

  • FDA's 90 Minute Video about Unapproved Drugs

 

  • Compliance Policy Guidance on Unapproved Drugs

 

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