Doctors say the drug, whose generic name is Propofol, can lead to cardiac arrest when the heart abruptly stops.
The drug Mylotarg, generic name Gemtuzumab ozogamicin, was FDA-approved for post-remission treatment of AML in patients over age 60 several years ago.
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Mutual and the Obama administration want that protection extended to the design of the drug, since the generic is an exact copy of the brand-name drug that has already been approved by the federal government.
Invokana has been subject to intense scrutiny and speculation because last year a similar drug, Forxiga (generic name dapagliflozin), developed by Bristol-Myers Squibb in partnership with AstraZeneca, was rejected by the FDA. The reason for the rejection was concern over liver damage and cancer risk, specifically breast cancer and bladder cancer.
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If there's no exact generic equivalent to the brand-name drug that you are taking, there may be similar drugs in the same class that are close enough.
The drug Diprivan, known by its generic name Propofol, is administered intravenously in operating rooms as a general anesthetic.
But a Consumer Reports analysis found that the FDA was as likely to warn about manufacturing issues at a brand-name drug factory as a generic one, Dr. Santa says.
In August AstraZeneca will lose patent rights on breast cancer drug Nolvadex, widely known by its generic name tamoxifen.
The Obama administration wants Big Pharma to stop paying generic drug competitors to delay releasing cheaper versions of brand-name drugs.
Mutual, however, argues that federal law preempts this type of claim, because the FDA had already approved its drug and federal law also requires a generic drug to have the same design as the brand-name medication ( here is the petition).
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More risky are cases where generic drugs are not functionally equivalent to the brand-name drug.
Big Pharma has managed to completely undermine Hatch-Waxman's intent, which was to put in place mechanisms that encouraged generic drug makers to challenge the weak patents often used to protect brand-name drugs.
Revlimid is the chemical cousin and heir to Celgene's first drug, Thalomid, which is still probably better known by its generic name, thalidomide.
According to the 2010 RBC Capital Markets study, when trial victories, settlements between drugmakers and dropped cases are combined, generic companies were able to bring their product to market before the brand-name drug's patent expired in 76 percent of the 371 drug patent suits decided from 2000 through 2009.
Such pay-for-delay deals arise when generic companies file a challenge at the Food and Drug Administration to the patents that give brand-name drugs a 20-year monopoly.
With billions of dollars at stake and neither company certain how it might fare in court, a brand-name manufacturer might prefer to pay its potential competitor substantial compensation to delay its generic drug and the generic maker might welcome a hefty payoff rather than face the uncertainties of litigation and marketing.
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