Pliva gets US OK for generic Zithromax
Barr Pharmaceuticals says its subsidiary Pliva has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application to manufacture and market azithromycin for Injection, 500mg vial, the generic version of Zithromax IV (azithromycin for injection). The company intends to launch its product during the first quarter of 2007.
Pliva/Barr's azithromycin will compete in a market that had total US sales of around $75.0 million, based on IMS data for the 12-month period ending November 2006.
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