Feature | May 17, 2012| Dave Fornell

FDA Approves Generic Versions of Blood Thinner Plavix

Generic clopidogrel expected to cut medical costs for cardiac patients

May 17, 2012 — The U.S. Food and Drug Administration (FDA) today approved generic versions of the blood-thinning drug Plavix (clopidogrel), which is expected to have a major impact on the cost to treat patients at risk of heart attack and stroke.

The drug is one of the most widely used pharmaceuticals. Although newer drugs have been introduced to compete against clopidogrel, the agent has remained the No. 1 selling antiplatelet agent. That dominance is expected to become stronger with the drug going generic and slashing its cost.

Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals and Teva Pharmaceuticals have gained FDA approval for 300 milligram (mg) clopidogrel. Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals have received approval for 75 mg clopidogrel.

Generic drugs approved by FDA are of the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those for brand-name drugs.

The agent helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries. The agent is also used in conjunction with surgical and interventional coronary disease therapies.

“For people who must manage chronic health conditions, having effective and affordable treatment options is important,” said Keith Webber, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research. “The generic products approved today will expand those options for patients.”

One issue with the drug is that up to one-third of patients cannot metabolize it. For this reason, clopidogrel has a boxed warning to alert healthcare professionals and patients that the drug may not work well for those with certain genetic factors. Tests are available to see if a patient will respond or not. For non-responders, newer drugs are available that are metabolized differently.

Clopidogrel also interacts with some medications, especially proton pump inhibitors such as Prilosec (omeprazole) and Nexium (esomeprazole). They can reduce the effect of clopidogrel, leaving a person at greater risk for heart attack and stroke.

For more information: www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/default.htm

Related Content

UAB, University of Alabama at Birmingham study, stroke prevention, non-valvular atrial fibrillation, NVAF
News | Atrial Fibrillation| October 25, 2016
A recent study from University of Alabama at Birmingham (UAB) researchers published in PLOS ONE compares different...
medicare bundled cardiac payments, CMS cardiology payments
Feature | Business| October 24, 2016 | By John W. Meyer, MPH, FACHE
(Editor’s note: This is the second part of a two-part series on the proposed Medicare five-year demonstration for
bioresorbable stents, bioabsorbable stents, visualizing the Absorb BVS, dissolving stent, disappearing stent on IVUS and OCT

A comparison of how the Abbott Absorb BVS appears with intravascular ultrasound (IVUS) on the left, and optical coherence tomography (OCT) of the right. The stent is difficult to visualize and sizing is critical, so both modalities can help in bioresorbable stent measurements and to confirm stent apposition. Left image from the Volcano IVUS system and the right image from St. Jude Medical's OCT system


Feature | Stents Bioresorbable| October 20, 2016 | Dave Fornell
There has been a lot of interest in the interventional community regarding the Abbott Absorb Bioresorbable Vascular S
Avinger, Pantheris atherectomy catheter, OCT, Lumivascular technology, expanded FDA indication, diagnostic imaging device
News | Atherectomy Devices| October 20, 2016
Avinger Inc. recently announced that the company has received expanded indications from the U.S. Food and Drug...
recall, alligator retrieval device, X-Celerator hydrophilic guidewire, UltraFlow flow directed micro catheters, Marathon flow directed micro catheters
News | Cath Lab| October 18, 2016
Medtronic plc announced last week that it has notified customers of a voluntary recall of certain lots of its Pipeline...
Inventory management, Cardinal, RFID inventory tracking, cath lab inventory
Sponsored Content | Whitepapers | Inventory Management| October 18, 2016
As healthcare moves into the era of bundled payments, providers need to be especially focused on ensuring delivery of
angioseal, angio-seal, terumo, St. Jude, vascular closure devices
News | Vascular Closure Devices| October 18, 2016
October 18, 2016 — Abbott and St. Jude Medical Inc.
3-D bioprinting, 3-D printing, printed organs, 3D bioprinting

3-D printed vessel made from living cells implanted in an animal to test feasibility of using such structures clinically. Blood vessels are a stepping stone to the creation of more complex 3-D printed organs made from biomaterials. Image from the South Carolina Project for Organ Biofabrication.


Feature | 3-D Printing| October 13, 2016 | Dave Fornell
The U.S. Food and Drug Administration (FDA) changed its rules concerning custom medical devices Oct.
Shockwave lithoplasty system, VIVA 16, Vascular Interventioanl Advances, VIA Physicians, late-breaking endovascular clinical trial results
News | Cath Lab| October 12, 2016
VIVA (Vascular Interventional Advances) Physicians announced a number of highly anticipated late-breaking clinical...
Overlay Init