Progen Pharmaceuticals’ metoprolol succinate extended-release tablets have received FDA approval in the United States for a new 25mg specification.

May 26, 2026  Source: drugdu 30

"/Recently, Zhejiang Jutai Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Progen Pharmaceuticals, received approval from the U.S. Food and Drug Administration (FDA) for a new 25mg PAS (Metoprolol Succinate Extended-Release Tablet) specification. This is another significant development following the FDA approval of the 50mg, 100mg, and 200mg specifications of the product in 2024, marking Progen Pharmaceuticals' comprehensive multi-specification coverage of this core formulation in the U.S. market.
Metoprolol succinate extended-release tablets are the world's first selective β1 receptor blocker, which can reduce the risk of bronchoconstriction. It is widely used in the treatment of hypertension, angina pectoris, and symptomatic stable chronic heart failure with left ventricular systolic dysfunction, and is a commonly used drug in the field of chronic heart failure. Data shows that in 2025, the sales of this drug in the US market were approximately $233 million.
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The successful approval of the 25mg specification further improves the product specification system, provides more flexible low-dose options for clinical use, and helps meet the individualized treatment needs of different patients.
Leveraging its integrated advantages in API and formulation production, Progen Pharmaceuticals has steadily expanded its formulation exports, with an increasing number of products covering overseas markets. The recent approval of all specifications for metoprolol succinate extended-release tablets marks another significant step forward in the company's internationalization of formulations. It also provides valuable experience for expanding overseas markets with more products, and is expected to further drive growth in formulation exports.


https://bydrug.pharmcube.com/news/detail/f85c8fc7a72fc9beb1fcadd85f452fe7

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