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Barr gets US FDA nod for generic Aredia injection
Montvale, New Jersey | Friday, August 22, 2008, 08:00 Hrs  [IST]

Barr Pharmaceuticals, Inc announced that its subsidiary, Pliva - Lachema a.s., has received final approval from the US Food and Drug Administration (FDA) for its generic version of Pfizer Inc's Aredia (pamindronate disodium) injection, 30mg/mL, 60mg/mL, and 90mg/mL. The company plans to launch its product in the fourth quarter of calendar 2008. With this approval, Barr's US generic injectable portfolio now totals eight products.

Barr's generic Aredia (pamindronate disodium) product will compete in a market that had total annual sales of approximately $21 million for the twelve months ended June 2008, based on IMS sales data.

Barr Pharmaceuticals is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.

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