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ANI Pharmaceuticals Announces the FDA Approval and Launch of Trimethoprim Tablets USP

Thursday, November 17, 2022

ANI Pharmaceuticals, Inc., today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Trimethoprim Tablets USP, 100 mg.

ANI’s Trimethoprim Tablets are the generic version of the Reference Listed Drug (RLD) of the same established name. The current annual U.S. market for Trimethoprim Tablets is approximately $16.8 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

"As we continue to focus on bringing niche limited-competition products to market, we are pleased to announce the FDA approval and commercialization of Trimethoprim Tablets,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

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