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USFDA nod for Lupin's Ceftriaxone

Our Bureau

Mumbai , Oct. 1

LUPIN Ltd has announced that the US Food and Drug Administration has approved the company's abbreviated new drug application for Ceftriaxone vials for injection. The vials come in 250 mg, 500 mg, 1 gm and 2 gm.

Ceftriaxone is the generic equivalent of Rocephin marketed by Roche. Lupin intends to launch the product in the US after the product patent expiry in July 2005. The market size of Rochepin is $655 million as per the IMS, according to a company release. The Indian pharma company is the first firm with an ANDA approval for Ceftriaxone, according to the company statement.

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