Orchid gets USFDA nod for injection, gets 6-mth exclusivity
Pharma firm Orchid Chemicals & Pharmaceuticals today said it has received the US drug regulator's nod for its Piperacillin and Tazobactam injection, used to treat infections caused by certain bacteria.
"The US Food and Drug Administration has also determined that Orchid is first applicant for the product and has accordingly granted 180-days generic drug exclusivity, under applicable provisions," Orchid Chemicals said in a filing to the Bombay Stock Exchange.
The company gets USFDA approval for its Abbreviated New Drug Application, the filing added.
These approvals cover Orchid's generic equivalent in 2.25 g and 3.375 g and 4.5 g vial as well as 40.5 g dosage forms and strengths, it said.
"We are not only the first generic product to be approved but also have been granted 180-days generic drug exclusivity," Orchid Chemicals & Pharmaceuticals Managing Director Raghavendra Rao said.
The company would be launching this product in marketing and distribution partnership with Apotex in the US, the filing said.
September 23, 2009