Teva’s Generic Pravachol Will Be Approved – With Exclusivity, FDA Decrees
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA has determined that a court dismissal does not constitute a decision under the “court decision trigger” provision, although the agency’s stance must be affirmed by the D.C. district court.
You may also be interested in...
Statin Prices Likely To Remain High After Zocor Exclusivity Win
Teva and Ranbaxy appear slated for 180 days of simvastatin exclusivity after federal court ruling postponing mass generic entry into the sector until 2007.
Statin Prices Likely To Remain High After Zocor Exclusivity Win
Teva and Ranbaxy appear slated for 180 days of simvastatin exclusivity after federal court ruling postponing mass generic entry into the sector until 2007.
FDA’s Trigger Policy For Generic Lawsuit Decisions “Facilitates Certainty,” Court Rules
The decision will uphold FDA’s newly created policy, barring a dissenting opinion from the District Court of Appeals.