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Mylan/Biocon Running Out Of Time To Get Insulin Approved Before US Transition

 
• By Michael Cipriano

After second complete response letter, Mylan and Biocon have just over six months to resolve manufacturing issues and obtain full approval or face having to resubmit the insulin as a biologics license application.

Time-flies
The clock continues to tick for Mylan and Biocon's insulin glargine NDA following another CRL.

After landing a second US complete response letter (CRL) for their follow-on to Sanofi’s Lantus (insulin glargine), Mylan NV and its partner Biocon Ltd. have just over six months to get their manufacturing issues under control and secure a full approval before having to resubmit the product under a biologics license application.

Biocon announced on 31 August that the CRL is related to observations the US Food and Drug Administration made during...

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