December 24, 2019: The first generic versions of the powerful Eliquis anticoagulant (apixaban) were approved by the U.S. Food and Drug Administration. UU. Monday.
"Today's approvals of the first apixaban generics are an example of how the FDA's generic drug program improves access to low-cost, safe and high-quality drugs," Dr. Janet Woodcock, director of the Evaluation Center and FDA Drug Research, said in an agency press release.
"These approvals mark the first generic approvals of a direct oral anticoagulant," Woodcock said. "Direct oral anticoagulants [blood thinners] they don't require repeated blood tests. "
The two types of generic tablets were approved to reduce the risk of stroke and systemic coagulation in the lungs of patients with non-valvular atrial fibrillation and for the prevention of deep vein thrombosis (DVT), which can lead to pulmonary embolism (clots pulmonary), in patients who have had hip or knee replacement surgery.
Atrial fibrillation is a heart rhythm disorder that increases the risk of blood clots. It is estimated that between 3 and 6 million Americans have atrial fibrillation, according to the Centers for Disease Control and Prevention. UU. Many of these individuals use anticoagulants or anticoagulant medications to reduce that risk, the FDA noted.
There is an increased risk of blood clots forming inside a blood vessel, or strokes, if a patient stops using apixaban too soon, the agency said.
Patients with cardiac valve prostheses should not take apixaban or patients with atrial fibrillation caused by a heart valve problem. As with other approved anticoagulant medications, bleeding, including fatal and fatal bleeding, is the most serious risk with apixaban.
Apixaban generic approvals were granted to Micro Labs Limited and Mylan Pharmaceuticals Inc.