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US nod for Orchid’s drug
Date: 17-09-2009Orchid Chemicals and Pharmaceuticals Ltd on Wednesday announced that it has received approvals from the US Food and Drug Administration for its anti-infection drug Piperacillin-Tazobactam, in injectible form.
These approvals cover Orchid’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. The US FDA determined that Orchid is a ‘first applicant’ for the products and granted 180-day generic drug exclusivity. Orchid will launch these products in marketing and distribution partnership with Apotex in the