PLx Pharma Inc. announced that the U.S. Food and Drug Administration (“FDA”) approved supplemental new drug applications (“sNDAs”) for its lead products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as “VAZALORE”), the first ever novel, liquid-filled aspirin capsule. In October 2020, the company submitted separate supplemental new drug applications (“sNDAs”) for each dose strength. The submissions were considered chemistry and manufacturing control (“CMC”) filings as they included information on a change in formulation and the new manufacturing site for VAZALORE 325 mg and a new product strength for the 81 mg dose. The submission for the 325 mg dose also contained the results of a clinical study, demonstrating VAZALORE's bioequivalence to immediate-release aspirin, further supporting the change in formulation. The submission for the 81 mg dose builds off the information in the original approved new drug application, as well as the recent sNDA submitted for VAZALORE 325 mg.