Navigation Links
FDA Orders Halt to Marketing of Unapproved Single-Ingredient Oral Colchicine
Date:9/30/2010

SILVER SPRING, Md., Sept. 30 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF).

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

The companies are expected to stop manufacturing single-ingredient oral colchicine within 45 days and must stop shipping this unapproved product in interstate commerce within 90 days. A small amount of unapproved colchicine is expected to be available after these dates until supplies are exhausted.

Many single ingredient oral colchicine products have been used by the medical community for decades. These and a variety of other medications have not received the mandatory modern-day FDA-approval required of all prescription drugs.

Colcrys is the only FDA-approved single-ingredient oral colchicine product available on the U.S. market. Approved by the FDA in 2009, Colcrys' prescribing information contains important safety data and recommendations on drug interactions and dosing not available with unapproved products.

The manufacturer of Colcrys, Mutual Pharmaceutical/URL Pharma, has established a Patient Assistance Program (PAP) and a Co-Pay Assistance Program (CAP) to ensure that all patients will be able to continue affordable access to colchicine. The company also has informed FDA that it will maintain the programs at a minimum until there is FDA-approved generic competition for Colcrys. The PAP covers three groups of people: those with insurance; those without insurance; and Medicare beneficiaries enrolled in Part D who do not want the cost of Colcrys to contribute toward their true out-of-pocket expenditures under Part D. The CAP helps eligible patients reduce their Colcrys prescription co-pay to no more than $25 per prescription. Specific information on these programs can be found at www.colcrys.com, www.needymeds.org, or by calling 1-888-811-8423.

Today's action is part of the FDA's broader initiative against marketed unapproved drugs, announced in a June 2006 Compliance Policy Guide describing the agency's risk-based enforcement approach for marketed unapproved drug products.

"The need for drugs to go through the FDA approval process is clearly demonstrated by our review of oral colchicine tablets," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research (CDER). "Without our safety review and proper drug labeling, the old standard of care would likely have continued, to the detriment of patients."

Unapproved versions of colchicine are not generic drugs. Generic drugs are approved by the FDA to assure that the approved generic drug products meet the same standards as the innovator drug. All single-ingredient oral colchicine products, other than Colcrys, that are currently being marketed are unapproved drugs and have never been evaluated by the agency.

"It is a priority for the FDA to get unapproved medications, such as older versions of single ingredient oral colchicine, either updated to conform to FDA's current approval standards or off the market," said Deborah M. Autor, director of CDER's Office of Compliance. "The FDA remains committed to ensuring that prescription drugs have the necessary FDA approval. We encourage companies to actively pursue approval or face the type of action announced today."

The FDA previously took action against unapproved colchicine for injection products on Feb. 6, 2008. This ongoing initiative is designed to bring all unapproved medications, including single-ingredient oral colchicine, up to modern-day safety, efficacy, labeling, and quality standards by ensuring that they comply with FDA approval requirements. The FDA is committed to working with companies to ensure that marketed drugs are safe and effective, and meet appropriate standards for manufacturing and labeling.

For more information:

Oral Colchicine Federal Register Notice

http://www.ofr.gov/inspection.aspx#reg_F

FDA's Unapproved Drugs Web site http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/default.htm

Media Inquiries: Elaine Gansz Bobo, 301.796.7567, elaine.bobo@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Quest Diagnostics Introduces ClariSure(TM) Test for Identifying Chromosome Abnormalities Associated With 85 Developmental Disorders in Children
2. S*BIO to Develop New JAK-2 Inhibitor for Treatment of Myeloproliferative Disorders and Hematological Malignancies
3. Hyperion Therapeutics Announces Enrollment of First Patient in Phase 1/2 Clinical Trial of GT4P in Patients With Urea Cycle Disorders
4. Mayo Clinic Physicians Report Findings from Research on Sleep Disorders
5. Bristol-Myers Squibb, New Jersey Childrens Hospital Launch Center for Immune System Disorders & Infectious Diseases Including HIV/AIDS
6. Study Finds Fever may Lead to Improved Behavior in Children with Autism Spectrum Disorders
7. Lexicon Initiates Phase 2a Trial of LX6171 Drug Candidate for Cognitive Disorders
8. MJFF and Merck Serono (EMD Serono in North America) Join Forces on $2-Million Initiative to Drive Treatments for PD-Related Cognitive Dysfunction and Mood Disorders
9. Rigel Announces Initiation of Phase 1 Clinical Trial of R348 for Rheumatoid Arthritis, Psoriasis and Other Immune Disorders
10. Intra-Cellular Therapies Presents Data on Its Schizophrenia and Cognition in Schizophrenia Programs at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders
11. Cytopia Nominates JAK2 Clinical Candidate for Myeloproliferative Disorders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/19/2017)... June 19, 2017  Researchers from DRUGSCAN ® ... will host a live, complimentary webinar titled, "Untangling methods ... to the real world" on Wednesday June 28, 2017 ... This webinar will feature interviews with recreational and ... the manipulation techniques abusers use to prepare opioid tablets ...
(Date:6/16/2017)... June 16, 2017  Exactly 50 years ago today, the ... later became known as the San Francisco "Summer of Love."  ... unveiling two radical innovations in strategic market research portals that ... marks the beginning of Northern Light,s "Summer of Love (For ... ...
(Date:6/14/2017)... 2017 The Bio Supply Management Alliance (BSMA) ... Fremont and the Biomedical Manufacturing Network to ... California by providing a platform ... fostering workforce development. The primary focus of this alliance ... as well as small and mid-sized biomedical companies. ...
Breaking Medicine Technology:
(Date:6/25/2017)... ... ... in the United States Senate on Thursday released their version of bill ... from the American Health Care Act, which the House passed in May, so the ... to take up the Senate version as-is, if it passes. , The following statements ...
(Date:6/25/2017)... ... 25, 2017 , ... CareSet Labs released the Root NPI Graph today at ... new, greatly improved version of the Doctor Referral teaming dataset commonly available from Medicare. ... subsequently called the the “Doctor Referral Dataset” as released by Medicare and “DocGraph” as ...
(Date:6/25/2017)... (PRWEB) , ... June 25, 2017 , ... June is Men’s Health Month ... the most common cancer among men in the U.S. and the third most common cause ... is estimated that one man in seven will be diagnosed with prostate cancer during his ...
(Date:6/24/2017)... ... June 24, 2017 , ... The Pennsylvania Athletic Trainers’ ... Bayfront and Erie Convention Center on June 8-10. The weekend consisted of ... bowl, award and scholarship presentations, and professional networking. , On Friday June ...
(Date:6/24/2017)... (PRWEB) , ... June 24, 2017 , ... The weather ... spend time outdoors. Home and business owners should be aware that the summer months ... lake. In fact, mechanical locks and keys can be negatively affected from direct exposure ...
Breaking Medicine News(10 mins):