Impax Laboratories Receives Tentative Approval for Generic Coreg CR Extended-Release Capsules

    Author Samara MalkinPosted on Categories Drug Manufacturers, HealthcareTags , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,
    Impax Laboratories

    Impax Laboratories, Inc. (NASDAQ:IPXL) has received tentative US FDA approval on its Abbreviated New Drug Application.

    The application was for a generic form of Coreg CR (carvedilol phosphate) extended-release capsules, in quantities of 10, 20, 40, and 80 mg.

    Impax’s Abbreviated New Drug Application will be eligible for final approval on the expiration of marketing exclusivity on May 7, 2018.

    According to IMS Health, carvedilol phosphate extended-release capsules had brand sales of around $206 million in the US for a 12-month period ending in October 2017, so final approval for Impax of the Abbreviated New Drug Application will spell good news for the company.

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    Author Samara Malkin
    About the author: Samara graduated from Simon Fraser University with a BA in English, minoring in Publishing and Creative Writing. One day she hopes to publish her very own novel, but in the meantime, she contents herself with blogging and editing. She currently specializes in writing financial news and analysis, as well as cryptocurrency news and information.