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  • Regulatory NewsRegulatory News

    FDA Aligns With Citizen Petition, Revises Draft Guidance on Pricey Generic Heart Drug

    Manufacturers looking to market generic versions of a heart medicine that has been around since the 18th century and seen its price rise by more than 600% in recent years will have to work with a new revised US Food and Drug Administration (FDA) draft guidance released Tuesday. The revised guidance aligns with a citizen petition filed by Concordia Pharmaceuticals , the manufacturer of the authorized generic version of the drug, known as digoxin (or by t...