Business OpportunitiesOrchid 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.
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"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.
Shares of Orchid Chemicals & Pharmaceuticals were trading at Rs 138.10 on the BSE, up 9.13 per cent from previous close.