ANI: Approval and Launch of Indomethacin Oral Suspension, USP

 ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension (OS), USP.

ANI’s Indomethacin OS is the generic version of the Reference Listed Drug (RLD) Indocin® Oral Suspension. The current annual U.S. market for Indomethacin OS is approximately $4.1 million, according to the latest estimates from IQVIA/IMS Health, a leading healthcare data and analytics provider.

https://www.globenewswire.com/news-release/2024/01/16/2809672/0/en/ANI-Pharmaceuticals-Announces-the-FDA-Approval-and-Launch-of-Indomethacin-Oral-Suspension-USP.html