PLx Pharma Shares Trading Higher On FDA Approval For Newly Formulated Vazalore Dose

The FDA has approved PLx Pharma Inc's (NASDAQ: PLXP) supplemental marketing applications for its lead products, Vazalore 325 mg and Vazalore 81 mg novel, liquid-filled aspirin capsule.

• In November last year, the company submitted separate supplemental marketing applications for each dose strength.
• The submissions were considered chemistry and manufacturing control filings. 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 U.S. commercial launch is expected in the third quarter.
• Vazalore 325 mg was approved in 2013, indicated as a pain reliever, fever reducer, and aspirin therapy in vascular indications.
• Price Action: PLXP shares are trading higher by 21.8% at $9.05 in market trading hours on the last check Monday.