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Avadel Wins Expanded Label for Lumryz

[ Price : $8.95]

FDA approves an Avadel Pharmaceuticals supplemental NDA for Lumryz (sodium oxybate) for treating cataplexy or excessive daytime sl...

Boston Scientific Recalls Obsidio Embolic Device

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Boston Scientific recalls (Class 1) its Obsidio Conformable Embolic device to update the use instructions due to a concern about r...

Neurodevelopmental Safety Studies in Neonatal Products

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FDA publishes a guidance outlining a framework for considering the types of long-term neurodevelopmental safety studies that could...

FDA Continues to Review Ocaliva sNDA

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FDA says it is continuing to review the sNDA submitted by Intercept Pharmaceuticals for its Ocaliva following an advisory committe...

AbbVie NDA for Parkinsons Drug Approved

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FDA approves an AbbVie NDA for Vyalev (foscarbidopa and foslevodopa), a subcutaneous 24-hour infusion of levodopa-based therapy fo...

Guide on Postoperative Nausea/Vomiting Drugs

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FDA posts a draft guidance entitled Postoperative Nausea and Vomiting: Developing Drugs for Prevention.

Comments Extended on Conformance Assessment Program

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Federal Register notice: FDA extends the comment period on a 9/23 notice about three draft guidance documents related to CDRHs Acc...

FDA Wants Integrated Drug Review Feedback

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Attorney Deborah Livornese says FDA wants user feedback on the NDA integrated review format it has been publishing for several yea...

Guide on ANDA Reconsideration Requests

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Federal Register notice: FDA makes available a final guidance requesting the reconsideration of an ANDA decision at the division l...

Staska Pharma Recalls Ascorbic Acid Solution

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Staska Pharmaceuticals recalls one lot of ascorbic acid solution for injection (500mg/mL, 50mL vials) due to the presence of glass...