Pharma major, Orchid Chemicals & Pharmaceuticals has got some relief from the US District Court in the legal tussle with the multinational pharma major, Wyeth Pharmaceutical
The US District Court for the District of Columbia has denied Wyeth Pharmaceutical’s motion for a Temporary Restraining Order (TRO) which was filed on Wednesday in connection with its lawsuit against the US Food and Drug Administration (US FDA) challenging the latter’s approval of Orchid’s Abbreviated New Drug Applications (ANDAs) for its Zosyn generic products Piperacillin and Tazobactam for injections.
Zosyn (piperacillin/tazobactam) is an injectable antibacterial combination product consisting of the semisynthetic antibiotic piperacillin sodium and the ?-lactamase inhibitor tazobactam sodium for intravenous administration.
In its Memorandum Opinion and Order, the court found that, “Wyeth has failed to demonstrate a likelihood of success on the merits” of its claim that the US FDA’s approval of Orchid’s ANDAs violated applicable US statutes, the company mentioned in its filing with the BSE.