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StocksMedium•8 April 2026•

1 min read

ANI Pharmaceuticals Launches Generic Monoket Following FDA Approval

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Key Facts

1ANI Pharmaceuticals received final FDA approval and launched Isosorbide Mononitrate Tablets.

2The drug is a generic version of the reference drug Monoket in 10 mg and 20 mg strengths.

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) has announced the final approval from the U.S. Food and Drug Administration (FDA) for its Isosorbide Mononitrate Tablets. The newly launched product is a generic version of the reference listed drug Monoket, available in 10 mg and 20 mg strengths. This launch follows the successful approval of the company’s Abbreviated New Drug Application (ANDA), marking a significant expansion of its generic product portfolio. By introducing this alternative, ANI Pharmaceuticals aims to provide cost-effective treatment options while driving new revenue streams in the U.S. market. Market analysts view the FDA approval as a bullish catalyst for the company, validating its regulatory and research capabilities. The move underscores ANI's ongoing commitment to strengthening its presence in the competitive generic pharmaceutical landscape and delivering value to its shareholders.