Zyla Life Sciences
http://www.egalet.com/
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Latest From Zyla Life Sciences
ANDA Suitability Petitions: The Timelines They Are A-Changin'
US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.
Lights, Camera, Goal Dates: Pharma Gets Going With ANDA Suitability Petitions
Sponsors return with US suitability petition submissions against the backdrop of GDUFA III new goals for the FDA's response to such petitions. Scrip tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.
ANDA Suitability Petitions: The Timelines They Are A-Changin'
US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.
‘Real World’ Opioid Abuse Data On OxyContin Again Under Review At US FDA
Resubmission comes more than four years after Purdue pulled an sNDA seeking to demonstrate ‘real-world’ abuse prevention.
Company Information
- Industry
- Biotechnology
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Pharmaceuticals
- Specialty Pharmaceuticals
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Drug Delivery
- Controlled Release
- Nasal
- Other Names / Subsidiaries
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- Egalet, Ltd.
- Egalet Corporation
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