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December 24, 2019First Generics for Eliquis Approved
December 24, 2019 – The U.S. FDA has approved the first generics for Eliquis® (apixaban – Bristol-Myers Squibb) tablets. The generics, which are manufactured by Mylan Pharmaceuticals and by Micro Labs, are approved for the same indications as the brand name product.
Eliquis first received FDA approval in 2012. It is indicated to:
- reduce the risk of stroke and systemic embolism in patients who have nonvalvular atrial fibrillation;
- provide prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; and
- to treat DVT and PE, as well as to reduce the risk of recurrent DVT and PE following initial therapy.
A black box warning cautions that premature discontinuation of treatment with apixaban can increase the risk of thrombotic events, which can occur when blood clots create blockages in the blood vessels. The black box warning also cautions that spinal or epidural hematomas may occur in patients who are treated with apixaban and receive neuraxial anesthesia or undergo spinal puncture. This can lead to long-term or permanent paralysis.
Recommended dosing is 5mg by mouth taken twice daily. The dose should be reduced to 2.5mg twice a day in patients who have at least two of the following: age greater than or equal to 80 years, body weight less than or equal to 60kg (132 pounds), or serum creatinine (a measure of kidney function) greater than or equal to 1.5mg/dL.
Launch and pricing information are not yet available for Mylan’s or Micro Labs’ generics.
