Pradaxa Rival Medication Rejected by FDA
What does it say about how dangerous Pradaxa may be when a competing drug that is expected by some to be the best anticoagulant on the market is denied by the Food and Drug Administration?
The FDA announced earlier this week that Eliquis, an anticoagulant medication from Bristol-Myers Squibb Co. and Pfizer Inc. had not won approval. Additionally, it also did not request that either company perform new clinical trials.
The blood thinning medication, which was designed - like Pradaxa - to prevent strokes, blood clots, and atrial fibrillation, had been the focus of an expedited review by the FDA beginning last November. However, by March both pharma companies reported that the FDA had postponed acting on the drug. The drug was officially denied on June 27.
"All of this [delay] is surprising given the widespread perception that Eliquis is a best-in-class product relative to already-approved novel oral anticoagulants Pradaxa and Xarelto," Sanford Bernstein analyst Tim Anderson said in a research note, according to Reuters.
This decision comes less than one week after the FDA denied a request by the makers of Xarelto – another anticoagulant drug - to expand its approval to treat acute coronary syndrome as well.
If both Eliquis and Xarelto are similar drugs to Pradaxa, and Pradaxa already has a troubled history when it comes to potential safety worries, how concerned should you be if you or a loved one are currently taking any of these blood thinning medications.
If you have been hurt by a dangerous drug, such as Pradaxa, call Sokolove Law today to learn more about possibly pursuing a Pradaxa lawsuit. For legal help, call (800) 581-6358.
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