FDA approves generic of Lialda®
Dublin - June 8, 2017 - Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced that Zydus Cadila has informed that the US Food and Drug Administration has given the final approval for Zydus Cadila to market a generic of Lialda® in the US market.
Zydus Cadila was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda®.
Cosmo is the sole manufacturer of Lialda® for Shire. In 2016 Cosmo's revenues from the manufacturing of Lialda® were EUR 13.2 million.
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