FDA Denies Approval For Stroke Drug
The FDA has denied approval for a stroke medication developed by New Jersey-based Grace Therapeutics. The injectable drug is designed to treat strokes resulting from ruptured brain aneurysms. Regulatory rejection was based on concerns regarding the company's chemistry, manufacturing, and controls. Grace Therapeutics plans to address these issues and resubmit the application for approval. No specific company name was provided in the report.
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Sources · 7 independent
NBC News Radio
“The FDA is denying approval for a grace therapeutics drug intended to treat a rare but often deadly type of stroke. The agency says it has issues with the chemistry, manufacturing and controls of the New Jersey based companies stroke drug.”
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