Court rejects Astellas bid for FDA injunction

Nice try [1], Astellas Pharma. The Japanese drugmaker sued the FDA to keep generic copies of its Prograf transplant drug off the market. But the court was less than sympathetic: It rejected Astellas' request for an injunction that would stop the agency from blessing any competing versions of the product.

The company told Bloomberg that it's deciding what to do next. But at this point, what are its options? Its patents on Prograf have expired. Its petition to get FDA to raise the bar for copycat forms of the transplant drug failed, and now that failure has been ratified in court. The agency also said "no" to the company's request that doctors be notified anytime a transplant patient was preparing to shift to a Prograf copy.

Meanwhile, Novartis has already launched its rival med. Rather than fighting the competition in court, it looks like Astellas is going to have to duke it out in the marketplace.

- read the Bloomberg story [2]
- check out the coverage [3] from Reuters

Related Articles:
Astellas loses bid to stave off copycat Prograf [1]
Astellas gets Japan's nod for new Prograf use
Astellas faces FDA delay on reformulated Prograf [4]