Agency gives nod to new loading dose of Plavix
FDA approves 300-mg strength of clopidogrel
The FDA has approved a 300-mg tablet of clopidogrel (Plavix, Sanofi-Aventis/Bristol-Myers Squibb). A 300-mg loading dose was already approved by the agency for non-ST-segment elevation acute coronary syndrome (ACS) patients to be given as soon as possible following hospital admission. The recently updated ACC/AHA treatment guidelines for UA/NSTEMI and the AHA Cardiopulmonary Resuscitation and Emergency Cardiovascular Care guidelines for ACS patients also both recommend a 300-mg loading dose of clopidogrel in conjunction with aspirin. According to the manufacturers, the new 300-mg tablet is bioequivalent to four 75-mg tablets, the other available strength of clopidogrel.
Click here to see more articles from Drug Topics Daily News.
To go to the Drug Topics homepage, click here.
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.
