The first generic versions of the powerful blood thinner Eliquis (apixaban) were approved by the U.S. Food and Drug Administration on Monday.This approval marks a significant step in improving access to affordable and high-quality medications for patients in need of anticoagulant therapy.
What the FDA’s Approval Means for Patients
“Today’s approvals of the first generics of apixaban are an example of how the FDA’s generic drug program improves access to lower-cost, safe and high-quality medicines,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in an agency news release.
“These approvals mark the first generic approvals of a direct oral anticoagulant,” Woodcock noted. “Direct oral anticoagulants [blood thinners] do not require repeated blood testing.”
Generic Apixaban: A Cost-Effective Solution for Stroke Prevention
The newly approved generic tablets of apixaban are primarily indicated for reducing the risk of stroke and systemic clotting in patients with non-valvular atrial fibrillation (AFib). Additionally, they are used in the prevention of deep vein thrombosis (DVT), a condition that can lead to life-threatening pulmonary embolism (lung clots) in patients who have undergone hip or knee replacement surgery.
Atrial fibrillation is a heart rhythm disorder that raises the risk of blood clots. It is estimated that between almost 3 and 6 million Americans have atrial fibrillation, according to the U.S. Centers for Disease Control and Prevention. Many of these individuals use anticoagulants or anti-clotting drugs to reduce that risk, the FDA noted.
FDA Guidance on Apixaban Use and Risks
There is an increased risk of blood clots forming inside a blood vessel, or strokes, if a patient stops using apixaban too early, the agency said.
Patients with prosthetic heart valves should not take apixaban nor should patients with atrial fibrillation that is caused by a heart valve problem. As with other approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, is the most serious risk with apixaban.
Approval of Generic Apixaban by Micro Labs and Mylan
The generic apixaban products were approved for manufacturing by Micro Labs Limited and Mylan Pharmaceuticals Inc., both of which are now authorized to market their versions of the drug. This move is expected to increase competition and drive down the cost of this vital medication, making it more accessible to patients who need it the most.
Why Generic Blood Thinners Matter
Generic medications have long been a cornerstone of affordable healthcare, offering patients the same therapeutic benefits as brand-name drugs at a significantly reduced price. The approval of generic apixaban will provide a much-needed cost-effective alternative to Eliquis, ensuring that more patients can benefit from its stroke prevention and clot-reduction capabilities.
