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ANI Pharmaceuticals announces FDA approval of ANDA for Indomethacin OS
The Fly

ANI Pharmaceuticals announces FDA approval of ANDA for Indomethacin OS

ANI Pharmaceuticals announced that it received U.S. FDA approval for the Abbreviated New Drug Application for Indomethacin Oral Suspension, USP. ANI’s Indomethacin OS is the generic version of the Reference Listed Drug Indocin Oral Suspension. The current annual U.S. market for Indomethacin OS is approximately $4.1M, according to the latest estimates from IQVIA/IMS Health, a healthcare data and analytics provider.

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