Immucell receives fourth complete letter of NADA for Nisin treatment for cows
Immucell announced a milestone in the development of its purified Nisin product. Immucell learned that the FDA has issued a technical section complete letter for the human food safety technical section of Immucell's new animal drug application, or NADA, for its Nisin-based intramammary treatment of subclinical mastitis in lactating dairy cows. There are five major technical sections to a NADA with the FDA. Immucell previously received three of the five technical section complete letters required for NADA approval. This fourth complete letter leaves just the manufacturing technical section remaining for product approval and market launch. A first submission of the CMC technical section is anticipated in the coming weeks. At least two sequential submissions will be required. Each submission is subject to a six-month review period by the FDA.