Bengaluru, India, June 02, 2018
“Following submission of our Insulin Glargine application under the 505(b)(2) regulatory pathway, we had agreed with the US FDA to provide additional clinical data in support of the manufacturing site change from Bangalore to Malaysia. Hence, the recent CRL was anticipated and built into our plan. Together, Mylan and Biocon are already executing on all required activities we had agreed upon with FDA, and they are progressing according to plan. We do not anticipate any impact to the previously communicated timing of approval and anticipated launch by our partner Mylan.”
– Company Spokesperson
