Once-daily beta-blocker OK'd for three indications
Carvedilol extended-release capsules (Coreg CR, GlaxoSmithKline), a new once-daily third-generation beta-blocker, has received FDA approval for three indications. The capsule utilizes Flamel Technologies' proprietary Micropump technology, which controls the release of drug from the capsule over 24 hours. Coreg CR can be used to treat hypertension, post-myocardial infarction left ventricular dysfunction, and mild to severe heart failure. According to Glaxo, shipments will begin in the first quarter of 2007.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
