Andrx Asks FDA To Reconsider Petition To Block Biovail Diltiazem ER Generic
Andrx is petitioning FDA to reconsider its denial of the firm's previous citizen's petition in an effort to prevent market entry of Biovail's generic version of Hoechst Marion Roussel's Cardizem CD after expiration of Andrx' exclusivity Dec. 19.
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Innovator pharmaceutical companies will not be able to block approval of generic drugs by using the citizen petition mechanism, according to FDA's Nov. 30 proposed rule to revise the petition process.
Andrx will launch a reformulated once-daily diltiazem product following the resolution of a patent suit with Cardizem CD manufacturer Hoechst Marion Roussel.
Forest/Biovail's Tiazac extended-release diltiazem will be relisted in the Orange Book as a reference listed drug, allowing submission of ANDAs for the brand.