Lupin bags USFDA approval for Mirabegron ER tablets to treat overactive bladder
The product will be manufactured at Lupin's facility in Nagpur, India.
Mumbai: Global pharma major Lupin Limited has announced that the Company has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Mirabegron Extended-Release Tablets, 25 mg, and 50 mg.
The product is a generic equivalent of Myrbetriq Extended-Release Tablets, 25 mg, and 50 mg, of Astellas Pharma Global Development, Inc.
Mirabegron is indicated for treating the overactive bladder or neurogenic detrusor overactivity but does not cure these conditions.
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Overactive bladder occurs when you cannot control your bladder contractions. When these muscle contractions happen too often or cannot be controlled, you can get symptoms of overactive bladder, which are urinary frequency, urinary urgency, and urinary incontinence (leakage).
The product will be manufactured at Lupin's facility in Nagpur, India.
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle-East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women's health areas.
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