Generic Versions Of Rytary Should Meet 3 Extra Standards, Impax Says
US FDA should refrain from relying on standard PK measurements for determining bioequivalence for the extended-release Parkinson's product.
You may also be interested in...
FDA worries about diverting resources to respond to 505(q) petitions, despite receiving lowest number in fiscal year 2015 since it began tracking requests.
But more data on abuse potential and efficacy could offer path for forward for oxycodegol even after the FDA product-specific advisory committee meeting for an opioid analgesic in more than a year goes very badly for the sponsor.
Nektar's novel opioid oxycodegol will be the first opioid analgesic taken up by an advisory committee in more than a year after the agency spent 2019 reevaluating its regulatory paradigm.