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) 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.
- BAUDETTE, Minn., Jan. 16, 2024 (GLOBE NEWSWIRE) -- 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.
- "With this approval, the FDA has granted Indomethacin OS a Competitive Generic Therapy (CGT) designation, with 180-day exclusivity.