Biotech Values

[exwannabe]

Re: the MNTA decision

"The Court, therefore, finds it unlikely that Sanofi will succeed on the merits of its claims."

"Accordingly,the Court concludes that Sanofi is unlikely to demonstrate that the FDA exceeded its authority under the FDCA when it approved
Sandoz’s ANDA despite having required Sandoz to submit additional
information comparing the impurity profiles of its generic
enoxaparin with Lovenox."

"Therefore, given the deferential standard of review that this Court must accord the FDA’s scientific determinations, the Court finds it unlikely that Sanofi will succeed in its argument that the FDA’s approval of generic enoxaparin is inconsistent with its past precedent."

This lawsuit is ancient history.