PLx Pharma announced that the US Food and Drug Administration (FDA) is providing clarification for the regulatory path forward for VAZALORE.
PLx Pharma (NASDAQ:PLXP) announced that the US Food and Drug Administration (FDA) is providing clarification for the regulatory path forward for VAZALORE.
As quoted in the press release:
Over the last year, the Company has refined and optimized its formulation, resulting in a high-quality and stable product. VAZALORE will deliver better absorption and improved GI safety for millions of patients at a high risk for cardiovascular events. In the Company’s recent interactions with the FDA, PLx agreed to provide some additional data on VAZALORE 325 mg dose strength to bridge the new formulation to the original approved formulation, and expects to meet with the FDA to finalize the data modeling components shortly. In addition, PLx gained alignment with the FDA on the necessary data required for approval for the 81 mg dose. PLx anticipates completing the data modeling and the submissions for both the 325 mg and 81 mg simultaneously in the second quarter of 2020. It is projected that this will shift the timing of the launch of both dosages of VAZALORE in the United States towards the end of 2020.
Additionally, the FDA has approved updated labeling for 325 mg dose strength, and the Company will apply the approved 325 mg labeling to the 81 mg labeling in the CMC submission planned for second quarter 2020.