Indian physicians who were involved in the controversial "superbug" NDM-1 study that was published in Lancet Infectious Diseases last month have been asked to confirm whether they followed various national guidelines and procedures required for the ...
A federal judge has denied Sanofi-Aventis 's request for a preliminary injunction that would have directed the US FDA to suspend and withdraw its approval of a generic version of Lovenox (enoxaparin sodium) from Sandoz (Novartis) and partner Momenta ...
The US FDA opposes the idea that applicants of generic or "follow-on" formulations of extended or delayed-release oral mesalamine drug products need to show bioequivalence to ulcerative colitis treatments Pentasa or Asacol through data from ...
Many pharmaceutical firms are expected to make objections to some of the new drug prices that were announced by the Greek government's pricing committee last week. Novartis and GlaxoSmithKline, two of the top five players in country in sales terms, ...
A federal judge has ordered that no generics makers can launch a generic version of Lilly's attention-deficit hyperactivity disorder drug, Strattera (atomoxetine), in the US for two weeks following the entry of a final judgement in an ongoing patent ...
