I know the possibility of legal complications has been discussed here, but this snippet from the WSJ sums it up starkly. Enthusiasm may be muted until this is cleared away.
The FDA's decision may provoke legal action. Amphastar says the FDA showed favoritism in picking Momenta, which helped the agency investigate deaths caused by imports of contaminated Chinese heparin in 2008. Amphastar's lawyers said Friday the company would do everything possible to change what it called a "wrong" decision.
Momenta Chief Executive Craig Wheeler cautioned analysts Friday that Sanofi also may bring legal action. Sanofi, which has said Lovenox is too complex to be copied safely, declined to comment on any possible litigation. Mr. Wheeler said Momenta and Sandoz had been working toward Friday's approval for eight years. "We have been looking forward to this particular call for a very long time," he said. "We have said in that past that we will be ready to launch upon approval, and we are."