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Resubmission comes more than four years after Purdue pulled an sNDA seeking to demonstrate ‘real-world’ abuse prevention.
Recent regulatory trends at US FDA offer no clear path to success for sponsors developing opioids. As 2018 concludes with only one approval and at least five rejections, firms will need new strategies if they hope to bring the
The potential blockbuster category for abuse-deterrent opioids has fizzled. A few stalwarts are pushing on, but the return on investment for many drug manufacturers has been disappointing. Scrip tracked how opioids approved in the last eight years have performed.
KemPharm is looking to sign a generic drug partner to launch its new brand opioid Apadaz, which says a lot about how the commercial promise of abuse-deterrent opioids has so far failed to materialize.
- Specialty Pharmaceuticals
- Controlled Release
- Other Names / Subsidiaries
- Egalet, Ltd.
- Egalet Corporation
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