That petition was denied. The company cited other aspects of the APA and due process violations. They alleged a danger to the public.
Intersting, on an issue raised here about reputation: "Biovail failed to present evidence that generic Wellbutrin will actually cause harmful health effects and, therefore, failed to prove the negative impact that an increase in the number of drug-induced seizures would have on its reputation."
I have no idea how Sanofi could prove that MNTA's drug is anymore dangerous than brand name Lovenox since it is darn near identical and there were no clinical trials. In the Biovail case they alleged harmful chemicals in some batches. No such issue will exist in our case.
The court concluded as follows: "The district court then went on to reject Biovail's assertion that no other interested parties would be harmed by the requested injunctive relief. When a generic drug is approved, the generic drug manufacturer is usually prepared to immediately fill its distribution pipeline with the approved product. Therefore, would-be manufacturers of generic Wellbutrin could be harmed by the TRO.
The district court then found that Biovail failed to establish or even allege that any of the applications awaiting FDA review represent a drug that is in fact unsafe, and thus, the public interest is not best served by delaying the marketing of the generic drugs at issue."
All in all, I am much more concerned about a Teva approval than I am this lawsuit.
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