ICCC - ImmuCell to delay resubmission of FDA application for Re-Tain
2023-06-28 18:14:23 ET
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.
More on ImmuCell:
- ImmuCell expects to resume full production in H2 2023
- ImmuCell GAAP EPS of -$0.30, revenue of $2.6M
- ImmuCell Corporation ( ICCC ) Q1 2023 Earnings Call Transcript
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ImmuCell to delay resubmission of FDA application for Re-Tain