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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