Benzinga | Jul 6, 2021 06:50AM EDT

ANI Pharmaceuticals Announces Refiling Of Cortrophin sNDA With FDA

ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced that the Company has re-filed its supplemental new drug application ("sNDA") for Cortrophin(r) Gel with the U.S. Food and Drug Administration ("FDA").

"We are delighted to have re-filed our sNDA for Cortrophin Gel in the last week of June. ANI has carefully reviewed every communication from the FDA with our internal subject matter experts and enlisted additional expert advice from industry consultants to make every effort to address all of the FDA's comments. Cortrophin Gel is an important product for ANI, and we look forward to bringing the product to market for patients who can benefit, if approved. I sincerely appreciate the efforts and dedication of the ANI team and our partners to support the re-filing," stated Nikhil Lalwani, Chief Executive Officer of ANI Pharmaceuticals.