Multinational pharmaceutical major Wyeth has filed a suit in the US District Court of Columbia against the USFDA relating to the agency’s approval of Orchid’s ANDAs for its generic products — Piperacillin and Tazobactam — for injections and also against the FDA’s decision on Wyeth’s Citizen Petition.
Orchid, in a filing with the BSE, stated that the matter has been heard briefly by the court. Based on a minute note filed in the court’s dockets late on Wednesday, the court has determined that it would issue Written Memorandum Opinion denying Wyeth’s motion for temporary restraining order on September 24, 2009 by noon time. <!–more–>
Prior to Wyeth’s motion, company’s generic products were already been launched in the US in distribution partnership with Apotex based on the USFDA’s approval of the relevant ANDAs.