Core Viewpoint - ImmuCell Corporation is initiating Investigational Product use of Re-Tain to test market acceptance while awaiting full regulatory approval [1][4] Company Developments - The controlled launch of Re-Tain aims to utilize existing inventory before its shelf-life expiration, although it is not expected to generate significant revenue or profit [2] - The company submitted its Non-Administrative New Animal Drug Application (NADA) in early January 2025, which included the fourth submission of the CMC Technical Section [3] - The critical path for NADA approval is clearing inspectional observations at the facilities of the company's contract manufacturer [3] Product Information - Re-Tain is a novel treatment for subclinical mastitis in dairy cows, designed to avoid FDA-required milk discard or pre-slaughter withdrawal label restrictions, providing an alternative to traditional antibiotics [6]
ImmuCell Announces Initiation of Investigational Product Use of Re-Tain®