Novartis speeds ahead of FDA in halting its distribution of its generic Zantac


Novartis did not wait for an FDA investigation as it halts worldwide distribution of its generic Zantac, after it was suspected that a cancer-causing impurity had been detected in the popular over the counter anatacid.

The FDA decided it was unnecessary for Novartis to recall the generic however European and Canadian regulators have taken a more aggressive approach by asking drug makers to stop distribution. Unlike a recall it means the stocks of the drugs already in the store can be sold.

Novartis announced: “A precautionary distribution stop of all Sandoz ranitidine containing medicines in all their our markets will remain in place until further clarification.” Novartis is set to perform an internal investigation to determine further details.

Sanofi, which sells branded Zantac, has decided not to take a similar approach, with no current plans to stop the distribution or manufacturing of Zantac. Sanofi is said to be working close with the FDA and has pointed out to the regulatory agency that the level of NDMA in Zantac barely exceeds the amount found in common foods.

NDMA is the same impurity that set of global recall in blood pressure medicines last year, with the FDA determining in the recall that NDMA and two other cancer causing agents can be created during certain manufacturing steps involving the use of solvents. The FDA has now set acceptable limits to the amount of NDMA than can be found.


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