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 a June 2019 pre-approval inspection of a Biocon facility in Malaysia
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