Pharma major Lupin Ltd on September 4 said it has launched its generic version of Mirabegron extended-release tablets used in the treatment of overactive bladder, following approval from the US health regulator.
The approval granted by the US Food and Drug Administration (USFDA) is for Mirabegron extended-release tablets of strength 50 mg, Lupin said in a regulatory filing.
Mirabegron extended-release tablets, 50 mg, is a generic equivalent of Myrbetriq of Astellas Pharma Global Development.
The estimated annual sales of Myrbetriq is $1.6 billion in the US, the Mumbai-based drug maker said, citing IQVIA MAT July 2024 data.
Last month, Lupin had launched a generic cancer treatment drug, Doxorubicin Hydrochloride Liposome injection, in single-dose vials, in the US market. The introduced the product after its alliance partner, ForDoz Pharma Corporation, USA (ForDoz) received approval from the USFDA, Lupin said in a statement.
(With PTI inputs)
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