ANI Pharmaceuticals (ANIP): FDA Update: Approval for Generic NSAID ....

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Tuesday, 02/27/2024 3:05:17 PM

Tuesday, February 27, 2024 3:05:17 PM

FDA Update: Approval for Generic NSAID ...

Michele B. Kaufman, PharmD, BCGP | February 27, 2024

New Generic NSAID
The U.S. Food & Drug Administration (FDA) approved an abbreviated new drug application for indomethacin oral suspension. This non-steroidal anti-inflammatory drug (NSAID) is a generic version of Indocin Oral Suspension.1

Indomethacin is approved to treat patients with rheumatoid arthritis, ankylosing spondylitis, severe osteoarthritis, acute painful shoulder (tendinitis and/or bursitis) and acute gouty arthritis. This suspension is advantageous for patients who are unable to swallow solid dosage forms.2

The current annual U.S. market for indomethacin oral suspension is approximately $4.1 million. This approval grants ANI Pharmaceuticals Inc. 180 days of market exclusivity.1

https://www.the-rheumatologist.org/article/fda-update-approval-for-generic-nsaid-new-boxed-warning-for-denosumab/