FDA Unapproved Drugs Initiative

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