Generic Equivalence Problems Come Up Again
In early May, Bloomberg news reported the FDA will be conducting studies into generic extended release Toprol XL after almost 3,500 adverse incident reports have amassed since March 2009.
In early May,
The FDA did conduct initial tests that showed the Toprol XL generic forms, metoprolol succinate, dissolved properly. However, based on the adverse incident reports, which Bloomberg News said were related to lack of effectiveness and side effects, the FDA
There are some similarities between this FDA action and its findings into a generic version of Wellbutrin XL 300 mg about 18 months ago. In October 2012, the
In that case, FDA had approved the Budeprion XL 300 mg dose based on extrapolated data based on budeprion XL 150 mg because of risk of seizures in the generic,
The generic forms of metoprolol succinate are manufactured by Wockhardt Ltd., Dr. Reddy’s Laboratories in India, and Mylan and Actavis in the United States.
Newsletter
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
Related Articles
- Everything to Know About FDA’s Push Towards Radical Transparency in 2025
September 17th 2025
- IQVIA and Veeva Join Forces to Improve Efficiency and Patient Outcomes
September 17th 2025
- Managing Background Therapies in the NIMBLE Phase III Trial
September 17th 2025
- Generative AI Transforms Clinical Study Report Development
September 16th 2025