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Avenue Therapeutics Inc.

www.avenuetx.com

Latest From Avenue Therapeutics Inc.

Keeping Track: Regeneron Ebola Antibody Cocktail Inmazeb Approved; Avenue Feels Pain From CRL; Scynexis Submits Oral Antifungal

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Approvals Drug Approval Standards

Intravenous Tramadol CRL Casts Shadow On Avenue’s Cipla Deal

Avenue’s two-stage deal with an arm of Cipla faces uncertainty following a US Complete Response Letter for its intravenous tramadol. The US firm says it is "very surprised" with the potential safety concern raised and plans to seek a meeting with the agency at the earliest to resolve the issue.

Value-Added Medicines Complete Response Letters

Intravenous Tramadol CRL Casts Shadow On Avenue’s Cipla Deal

Avenue’s two-stage deal with an arm of Cipla faces uncertainty following a US Complete Response Letter for its intravenous tramadol. The US firm says it is "very surprised" with the potential safety concern raised and plans to seek a meeting with the agency at the earliest to resolve the issue.

Policy & Regulation Drug Review
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  • Pharmaceuticals
    • Drug Delivery
    • Specialty Pharmaceuticals
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