ANI Pharmaceuticals Says Its Supplemental NDA For Purified Cortrophin Gel Accepted

(RTTNews) - ANI Pharmaceuticals, Inc. (ANIP) on Tuesday said the FDA has accepted the company's supplemental New Drug Application for Purified Cortrophin Gel for multiple indications including multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome.

A decision by the FDA on the application is expected on October 29, 2021.

"We look forward to further productive engagement with the FDA, and in parallel, we are focused on preparations for the launch of Cortrophin Gel," stated Nikhil Lalwani, Chief Executive Officer of ANI Pharmaceuticals.

Purified Cortrophin Gel is a purified adrenocorticotropic hormone (ACTH) previously approved in the U.S. for indications including multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome.