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Mylan’s EpiPen Exclusivity Saved Again As Teva Reports CRL

 
• By Jessica Merrill

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.

It looks as though Mylan NV will enjoy exclusivity for its EpiPen Auto-Injector (epinephrine) for the treatment of severe anaphylaxis into 2017 at a minimum now that Teva Pharmaceutical Industries Ltd.’s application for a generic copy has been pushed back by FDA.

Teva revealed in a Securities & Exchange Commission filing Feb. 29 that it received a complete response letter from FDA related to its abbreviated new drug application (ANDA) for epinephrine

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Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
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Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
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Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
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