Newly Approved Generic Blood Thinner Saves Costs
The FDA recently approved the first ever generic version of the blood thinner Plavix. Clopidogrel Tablets USP, 75 mg and 300 mg is now approved to treat patients who have had a recent stroke, heart attack or blocked artery.
Mylan’s Pharmaceuticals Inc. has received approval from U.S health regulators.
“For people who must manage chronic health conditions, having effective and affordable treatment options is important Keith Webber, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research, says “Having affordable treatment options are important for people who have serious health conditions.”
Clopidogrel has a boxed warning to alert healthcare professionals and patients that the drug may not work well for those with certain genetic factors that affect metabolism. Patients can be tested for these genetic factors.
In addition, certain medicines, such as proton pump inhibitors Prilosec (omeprazole) and Nexium (esomeprazole), reduce the effect of clopidogrel, risking chance of heart attack and stroke.
As with other blood thinners Clopidogrel may cause excessive bleeding, which can be serious and sometimes result in fatalities.
While taking the drug, people may bruise and bleed more easily, and it may take longer for bleeding to stop. Clopidogrel is dispensed with a patient Medication Guide for safety information.
Mylan’s Pharmaceuticals Inc. has received approval from U.S health regulators.
Generic drugs approved by FDA are of the same quality and strength as brand-name drugs. Quality standards are the same as those for brand-name drugs.
The following companies have received FDA approval for 300 mg clopidogrel:
- Teva Pharmaceuticals
- Mylan Pharmaceuticals
- Gate Pharmaceuticals
- Dr. Reddy's Laboratories
The following companies have received FDA approval for 75 mg clopidogrel:
- Torrent Pharmaceuticals
- Teva Pharmaceuticals
- Sun Pharma
- Roxane Laboratories
- Mylan Pharmaceuticals
- Aurobindo Pharma
- Apotex Corporation
The generics should be available in pharmacies shortly. Walmart and Sam's Club pharmacies nationwide will begin selling generic Plavix on Saturday May 20, for about $40 a month or a $10 co-pay with insurance.
Plavix is taken by millions of people every day and prevents platelets in the blood from clumping together. Brand-name Plavix is marketed jointly by Bristol-Myers Squibb Co. and Sanofi SA.