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ImmuCell to delay resubmission of FDA application for Re-Tain

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Group of cows together gathering in a field, happy and joyful and a blue cloudy sky.

Clara Bastian

ImmuCell (NASDAQ:ICCC) said it is delaying resubmission of its market application to the US Food and Drug Administration for its dairy cattle medication Re-Tain by one month in order to better prepare for a re-inspection of its manufacturing facilities.

The animal health company said the resubmission had originally been scheduled for Q2. Re-Tain is a treatment for subclinical mastitis in dairy cows.

The FDA declined to approve Re-Tain in July 2022. At the time, ImmuCell said the principal remaining hurdle was a re-inspection of its manufacturing facility.

Since then, the company has grappled with contamination issues that forced it to cut back on production. In mid-June, the company said it expected to resume full production during the second half of 2023.

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