ANI Pharmaceuticals Announces the FDA Approval and Launch of Indomethacin Oral Suspension, USP
BAUDETTE, Minn. , Jan. 16, 2024 (GLOBE NEWSWIRE) — ANI Pharmaceuticals, Inc. (ANI or the company) (Nasdaq: ANIP) announced that it has obtained approval from the U. S. Food and Drug Administration. U. S. Food and Drug Administration (FDA) for the new abbreviated product. Drug Application (ANDA) for Indomethacin Oral Suspension (OS), USP. ANI’s Indomethacin OS is the generic edition of Indocin® oral suspension of the Listed Reference Drug (RLD). The annual market in the U. S. The U. S. Drug Estimate for Indomethacin OS is about $4. 1 million, according to the latest U. S. Drug Enforcement Estimates