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:9/18/2017)... KALAMAZOO, Mich. , Sept. 18, 2017 ... , and OptiMed Specialty Pharmacy of Kalamazoo, ... offer a strategic hub service that expedites and streamlines ... personal spirometer, Spiro PD 2.0, and wellness management services.  ... is a medical device used to measure lung function ...
(Date:9/12/2017)... , Sept. 12, 2017   EcoVadis , the leading platform ... published the first annual edition of its Global CSR Risk and Performance ... evaluated by EcoVadis, based on Scorecard Ratings that analyzed nearly 800,000 data ... ... ...
(Date:9/9/2017)... 8, 2017 ... Unit coming to Washington DC ... When: Tuesday, September 12 th – Monday, September 18 th .The ... free MRI brain scans to the public.Where:  BTF,s ... at 501 K Street NW, Washington, D.C.What:BTF brings its nationwide initiative, the ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... Lori R. Somekh, founder of the Law Office of Somekh & Associates ... special needs planning attorneys. “Membership in ElderCounsel helps our office remain up to date ... elder law attorneys nationwide,” said Somekh. , ElderCounsel was founded by ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional ... action towards gender equality at their inaugural Summit in New York City in June. ... a social audience of over 3 million. To watch the Mobilize Women video, ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader in ... awarded a contract by the Center for Medicare and Medicaid Services (CMS). The ... enterprise use of Agile methodologies in a consistent and high value manner across ...
(Date:10/12/2017)... ... 12, 2017 , ... CitiDent and San Francisco dentists, Dr. ... Oventus O2Vent technology. As many as 18 million Americans are estimated to suffer ... Oral appliances can offer significant relief to about 75 percent of people with ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical Informatics (ACMI) will ... during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual ... F. Collen, a pioneer in the field of medical informatics, this prestigious award is ...
Breaking Medicine News(10 mins):