On Friday, the U. S. Food and Drug Administration approved the first generic version of Lovenox used for blood clot treatment, a product of Sandoz generic drug unit of Switzerland's Novartis AG.
But, Sanofi-Aventis raised doubts on the approval of the said drug on Monday. They demanded the U. S. court to obstruct the approval, as the federal regulators did not take appropriate considerations, while approving the generic version.
After last week's FDA approval, Sanofi’s shares climbed down by 4.3% and it expressed that they also expected a fall in their income by 4%.
Sanofi debated that the FDA didn’t ensure that Sandoz's drug has the same active ingredient as Lovenox and by giving a nod to the drug; the FDA authorities just relied on the fact that Sandoz followed Sanofi’s proprietary information. It showed FDA’s impulsiveness.
The U. S. Court has been asked by Sanofi for restricting the medicine temporarily and initiating an introductory ban on the drug, which would eventually led FDA to take back its approval.
Sanofi said, “FDA’s decision will cause Sanofi-Aventis irreparable harm and may result in entry into the market of a generic product that is not clinically equivalent to Lovenox with respect to safety or efficacy".
Last week, Novartis told that after getting the approval, they had started delivering the drug to the market.