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Keeping Track: Gavreto, Sogroya Bring Annual CDER Novel Approvals To 40; New Analgesic Products Make It Past US FDA

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

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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.

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