Generic Version of Sanofi-Aventis’ Multaq Gets Tentative Approval

Alembic Pharmaceuticals has gotten tentative approval for its abbreviated new drug application (ANDA) for dronedarone, a generic equivalent to Sanofi-Aventis’ anti-arrhythmic Multaq, which the FDA approved in 2009.

Dronedarone is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation.

Tentative ANDA approvals are issued for generics that meet the substantive requirements for approval, but the drug product may not be marketed until the ANDA gains final agency approval.