Latest From kaleo Inc.
The acting commissioner's statement is intended to clarify "persistent misunderstanding" about the label for the opioid overdose rescue medication's injectable formulation.
Opioid overdose treatments containing naloxone or nalmefene are now eligible for expedited ANDA review in a bid by the FDA to improve patient access.
In announcing expedited assessments for new naloxone ANDAs, the agency also offers guidance to sponsors of discontinued products considering a return to marketing.
- Medical Devices
- Drug Delivery
- Therapeutic Areas
- Immune Disorders
- Intelliject Inc.
- North America
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- kaleo Inc.
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T. Spencer Williamson, IV, Pres. & CEO
Christopher T Schools, CFO
Kristopher D Ford, VP, Bus. Dev.
Eric Edwards, MD, PhD, VP, R&D & CMO
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