Lupin gets US FDA approval for Ceftriaxone 10gm vials
New Delhi, Sep 14 (UNI) Lupin Pharma today said the US Food and Drug Administration (US FDA) has approved its abbreviated new drug application (ANDA) for its Ceftriaxone Injection 10 gram vials (Pharmacy bulk pack).
Ceftriaxone is the generic equivalent of Rocephin marketed by Roche.
The Company had launched the 250 mg, 500 mg, 1 g and 2 g strengths of Ceftriaxone vials upon patent expiry in July, 2005.
''The approval of our Ceftriaxone 10mg ANDA completes the entire Ceftriaxone product family. Again our preparedness for execution enables us to launch this product immediately,'' company's Managing Director Dr Kamal Sharma said.
The Company has agreements with Baxter Healthcare Corporation for the US hospital market and with Henry Schein for the physician offices.
With this approval, the company now has 15 ANDAs approved by the US FDA.
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