Zydus Lifesciences gained 3.79% to Rs 401.35 after its US subsidiary, Zydus Pharmaceuticals (USA) Inc. received final approval from the United States Food and Drug Administration (USFDA) to market Mirabegron extended-release tablets.
Zydus Life was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Mirabegron extended-release tablets and therefore is eligible for 180 days of shared generic drug exclusivity for the drug.The approved abbreviated new drug application (ANDA) is generic equivalent of Myrbetriq extended-release tablets of Astellas Pharma Global Development, Inc.
Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.
According to IQVIA MAT August 2022, Mirabegron extended-release tablets had annual sales of $2.42 billion in the United States.
The group now has 324 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The company's consolidated net profit fell 11.7% to Rs 518.3 crore on a 1.8% increase in total income from operations to Rs 4,072.7 crore in Q1 FY23 over Q1 FY22.
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