Pharma major Orchid Chemicals & Pharmaceuticals Ltd has received approvals from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug applications (ANDAs) for Piperacillin and Tazobactam for injection.
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 U.S. FDA has also determined that Orchid is a ‘first applicant’ for the products and has, accordingly, granted 180-day generic drug exclusivity, under applicable provisions. Orchid would be launching these products in marketing and distribution partnership with Apotex in the U.S., says a release from the company
“This is a great milestone in our U.S. generics journey. We are not only the first generic product to be approved but also have been granted 180-days generic drug exclusivity. These approvals demonstrate Orchid’s world-class technological and regulatory skills. Given the premium nature of this life-saving antibiotic and our first generic status with exclusivity, we anticipate significant contribution to our revenues and profitability from this product in the ensuing quarters,” the release quoted K. Raghavendra Rao, Managing Director, as saying.