Catalyst Pharma sues FDA over approval of cheaper rival drug


12 June 2019 - Catalyst Pharmaceuticals Inc, which has come under fire for the high price tag on its rare disease drug, on Wednesday sued the U.S. Food and Drug Administration to challenge the recent approval of a lower-cost rival drug.

The lawsuit alleges that the approval of Ruzurgi, a rival drug from privately held Jacobus Pharmaceutical Co, in May violated provisions of FDA regulations and Catalyst’s rights to exclusivity for its drug, Firdapse.

For years, patients were able to access the same drug for free from Jacobus, a small, family-run company in New Jersey, through an FDA program called “compassionate use”.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , US