Sandoz gains FDA appro for generic Toprol

Sandoz, the generics business of Swiss drug major Novartis, says that the US Food and Drug Administration has granted final approval to its Abbreviated New Drug Application for metoprolol succinate 50mg extended release tablets, a generic equivalent of AstraZeneca's cardiovascular drug Toprol XL.

Bernhard Hampl, president of Sandoz in the USA, said the clearance of the product "will be a strong complement to our existing product line, which includes metoprolol succinate 25mg extended release tablets." Launch plans and timing for metoprolol succinate 50mg ER have not been finalized by Sandoz.

Separately, USA-based Watson Pharmaceuticals revealed that it had given up its 180-day period of exclusivity for its generic 50mg formulation of metoprolol succinate, which it gained as first-to-file for a copy version of the drug, under the terms of a deal with Sandoz, whereby both companies will share profits on its sales.