Mylan (MYL) - Get Report shares were steady Tuesday after the Food and Drug Administration cleared the generic-drug maker's version of Eliquis, a tablet taken to reduce stroke risks and pulmonary embolisms.
The generic, apixaban, is designed for patients with nonvalvular atrial fibrillation and those who have undergone hip or knee replacement surgery. It’s also used to treat deep vein thrombosis.
The FDA’s clearance applies to closely held MicroLabs of India as well as Mylan, based in the U.K.
The FDA’s generic-drug program "improves access to lower-cost, safe and high-quality medicines,” Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, said in a statement.
“These approvals mark the first generic approvals of a direct oral anticoagulant. Direct oral anticoagulants (blood thinners) do not require repeated blood testing.”
The approval is part of an FDA program called the Drug Competition Action Plan, which is meant to give patients access to more affordable medicine.
In the first nine months of 2019, the drug generated $3.1 billion for Pfizer and $5.4 billion for Bristol-Myers, according to MarketWatch.
Morningstar analyst Soo Rominoff put fair value for Mylan stock at $20 prior to the news. Morningstar gives Mylan a three-star rating out of a possible five.
Mylan shares at last check stood at $19.89, off 0.2%. They earlier on Tuesday traded up nearly 1%. The stock has dropped 24% over the past year, compared to a 37% gain for the S&P 500.