Indian generic player Orchid Pharmaceuticals announced in a press release Here that company has received final approval from US regulatory authority USFDA to market Piperacillin and Tazobactam for Injection’s generic equivalents in 2.25 g, 3.375 g and 4.5 g vial as well as 40.5 g (Pharmacy Bulk Package) dosage forms and strengths. Importantly, Orchid has further confirmed that they have received 180 days first to file generic exclusivity for this important product.
Innovator’s Request for Temporary Restraining Order
Subsequently, in an attempt to block generic launch, innovator Wyeth 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.
US court denied Temporary Restraining Order
On September 24, 2009, the US District Court for the District of Columbia denied Wyeth Pharmaceutical's motion for a Temporary Restraining Order (TRO). Wyeth's request for TRO was filed in connection with its lawsuit against the US FDA challenging the US FDA's approval of Orchid's ANDAs for its generic products, Piperacillin and Tazobactam for Injections. The Court rejected Wyeth's requests and denied the TRO.
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.
Orchid is pleased with this result and will continue to protect its approved ANDAs for its Piperacillin and Tazobactam for Injections and also continue to supply the products to its distribution partner, Apotex Corp., for marketing and distribution in the US.
Source: http://www.orchidpharma.com/
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