Naloxone distribution programs ask that the cheaper generic injectable formulation have the same community-use language in its label as the nasal spray and auto-injector so they can maximize their distribution efforts.
The US FDA's approval of a generic version of Adapt Pharma Ltd.'s Narcan (naloxone hydrochloride) nasal spray may represent an advance in the opioid overdose treatment's availability, but public health advocates argue a simple labeling change may prove more effective.
Many community health programs, who distribute naloxone to opioid users, often on small budgets, say that the label for generic...
Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
