Zydus Lifesciences Launches Mirabegron Extended-Release Tablets in the US Market

On April 22, 2024, Zydus Lifesciences Ltd informed in an exchange filing that the company launched Mirabegron Extended-Release tablets in the United States of America.

Details of the New Launch 

Zydus Lifesciences Limited announces the launch of Mirabegron Extended-Release Tablets, 25 mg, in the United States market. The company had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg.

Zydus Lifesciences Limited is one of the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg, in the USA market. The company is also set to launch Mirabegron Extended-Release Tablets, 50mg, soon.

Mirabegron is approved for treating symptoms of overactive bladder (OAB), including urge urinary incontinence, urgency, and urinary frequency. This drug will be manufactured at the Zydus Group’s formulation manufacturing facility in Ahmedabad SEZ, India.

Commenting on the new launch, the CEO of Zydus Americas, Dr Punit Patel, said, “As one of the first suppliers, we are pleased with the launch of generic Mirabegron, which will improve access and availability of the generic product for patients in the US market. This is a significant launch for us, which will strengthen our growth plans in the US market in the current fiscal.”

The company stated that Mirabegron Extended-Release Tablets USP 25mg and 50mg had annual sales of USD 2.42bn in the US (IQVIA MAT February 2024). The group now has 393 approvals and has so far filed over 460 (as of December 31, 2023) ANDAs since the commencement of the filing process in FY 2003-04.

About Zydus Lifesciences Limited 

Zydus Lifesciences Limited, which was previously known as Cadila Healthcare Limited, is a leading Indian Pharmaceutical company. The company is involved in the Research and Development (R&D), manufacturing, marketing and distribution of pharmaceutical products around the world. As of March 2023, the company has 35 manufacturing facilities.

On April 22, 2024, the share price of Zydus Lifesciences Ltd opened at ₹936.15, touching the day’s high at ₹950.00, as of 9:43 AM on the NSE.

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