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BioPharmaceutical Regulation Approvals

Mylan’s EpiPen Exclusivity Saved Again As Teva Reports CRL

This article was originally published in The Pink Sheet Daily

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Executive Summary

Launching a competing epinephrine product has proved challenging, which is good news for Mylan. Teva disclosed the receipt of a complete response letter to its ANDA, just months after Sanofi voluntarily recalled Auvi-Q due to inaccurate dose delivery.

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