Sandoz Requests TRO to Block FDA Approval of Generic Zocor Tomorrow
Bloomberg News is reporting tonight that Sandoz, the generics arm of Novartis AG, filed a request for a temporary restraining order today in an attempt to prevent the FDA from granting Ivax and Ranbaxy final approval tomorrow to market generic Zocor (simvastatin).
The motivation behind Sandoz's eleventh hour request is not entirely clear, especially because it appears from the FDA website that Sandoz does not have an ANDA on file to market its own generic version of Zocor. In the Bloomberg News article, Sandoz seems to explain that it filed its TRO request in order to avoid a precedent that might affect other ANDA approvals in the future. However, that justification seems suspicious--the FDA has appealed the district court decision that effectively ordered the FDA to grant final approval to Ivax and Ranbaxy, and the appeal is on an expedited schedule. If the FDA's appeal is successful, the precedent Sandoz fears would be avoided.
Besides Ivax and Ranbaxy, the other simvastatin ANDA applicants are Aurobindo, Cobalt, and Teva. Ivax is itself a unit of Teva.
According to the Bloomberg News article, a hearing is scheduled for 10 a.m. tomorrow in the U.S. District Court for the District of Columbia to decide Sandoz's request for a TRO. Teva says it will vigorously fight Sandoz's request.
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