Noven MethyPatch submission
This article was originally published in Pharmaceutical Approvals Monthly
FDA accepts Noven's June 27 NDA for MethyPatch, a once-daily methylphenidate patch for attention deficit disorder. The NDA, which was previously delayed by "unsuccessful" elements of a Phase III trial, contains two Phase III studies, including a trial in 200 six to 12 year olds showing a statistically significant improvement in attention and behavior versus placebo (Pharmaceutical Approvals Monthly, May 2002, p. 28
You may also be interested in...
A Phase III trial testing the antibody-drug conjugate sacituzumab govitecan was stopped early for efficacy, boding well for the BLA pending at the US FDA.
Deal Snapshot: Six companies seek to collect convalescent plasma from COVID-19 survivors to quickly develop hyperimmune immunoglobulin therapy for serious complications of the virus.
Pharmaceutical companies struggling to keep up with coronavirus-related supply chain havoc asked to keep the US regulator informed as situation unfolds.