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On July 08, 2014, A PIND meeting held between Novus and FDA was successfully and the Agency agreed Vancomycin for Injection to be submitted under 505 (b)(2) NDA pathway.
After PIND meeting; FDA headquarter, on July 08, 2014
On Aug. 25, 2015, toxicity studies protocol for Vancomycin for Injection was submitted.
On Nov. 25, 2015, toxicity studies for Vancomycin for Injection started.
On Dec. 22, 2015, administration for toxicity studies was successfully completed.
On March 16, 2016, Vancomycin for Injection IND was submitted to FDA.
On March 12, 2016, FDA approved to conduct clinical studies.
On Jun. 01, 2016, administration for BE study started.
On Jun. 10, 2016, administration for BE study was successfully completed and the satisfied results were obtained.
NDA dossier is under active preparation and it proposes to be submitted in late 2016 or early 2017.