Novartis Ritalin LA becomes "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Novartis receives "approvable" letter Oct. 1 for once-daily Ritalin LA (methylphenidate) for attention deficit hyperactivity disorder. The company anticipates approval of the NDA, submitted November 2000, in the fourth quarter. Novartis is also awaiting final approval of a single-isomer version of Ritalin (dexmethylphenidate) licensed from Celgene, which was found"approvable" Aug. 21. Ritadex is the proposed name for that product
You may also be interested in...
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.
Stay Or Exit? Global Health Players Ponder New China Trajectory
It's again the time of year when global CEOs descend on China's capital to discuss strategies. This year, however, the mood is different.