• Connect with us
    • Information
      • About Us
      • Contact Us
      • Careers
      • Partnerships
      • Advertise With Us
      • Authors
      • Browse Topics
      • Events
      • Disclaimer
      • Privacy Policy
    • Australia
      North America
      World
    Login
    Investing News NetworkYour trusted source for investing success
    • North America
      Australia
      World
    • My INN
    Videos
    Companies
    Press Releases
    Private Placements
    SUBSCRIBE
    • Reports & Guides
      • Market Outlook Reports
      • Investing Guides
    • Button
    Resource
    • Precious Metals
    • Battery Metals
    • Base Metals
    • Energy
    • Critical Metals
    Tech
    Life Science
    Pharmaceutical Market
    Pharmaceutical News
    Pharmaceutical Stocks
    • Pharmaceutical Market
    • Pharmaceutical News
    • Pharmaceutical Stocks
    pharmaceutical investing

    PLx Pharma Provides Regulatory Update on VAZALORE

    Danielle Edwards
    Jan. 06, 2020 06:48AM PST
    Pharmaceutical Investing

    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.

    Click here to read the full press release.

    plx pharmapharmaceutical investingnasdaq:plxp
    The Conversation (0)

    Go Deeper

    AI Powered
    Large pharmaceutical pill with gold dollar sign in the middle. Stock tickers and charts in the background.

    Top 5 Small-cap Pharma Stocks of 2025

    Pfizer Reports First-Quarter 2023 Results

    Pfizer Reports First-Quarter 2023 Results

    Latest News

    Outlook Reports

    Resource
    • Precious Metals
      • Gold
      • Silver
    • Battery Metals
      • Lithium
      • Cobalt
      • Graphite
    • Energy
      • Uranium
      • Oil and Gas
    • Base Metals
      • Copper
      • Nickel
      • Zinc
    • Critical Metals
      • Rare Earths
    • Industrial Metals
    • Agriculture
    Tech
      • Artificial Intelligence
      • Cybersecurity
      • Gaming
      • Cleantech
      • Emerging Tech
    Life Science
      • Biotech
      • Cannabis
      • Psychedelics
      • Pharmaceuticals

    Featured Pharmaceutical Investing Stocks

    Invion Limited

    IVX:AU

    Cardiol Therapeutics

    CRDL:CA
    More featured stocks

    Browse Companies

    Resource
    • Precious Metals
    • Battery Metals
    • Energy
    • Base Metals
    • Critical Metals
    Tech
    Life Science
    MARKETS
    COMMODITIES
    CURRENCIES
    ×