Final approval from US FDA for Zydus’ mirabegron
Indian generics major Zydus Lifesciences (NYSE: ZYDUSLIFE) has received final approval from the US Food and Drug Administration (FDA) to market mirabegron extended-release tablets USP 25mg and 50mg, a generic version of Japanese pharma major Astellas’ (TYO: 4503) urinary drug that is sold under the trade names Betmiga and Myrbetriq.
Zydus, formerly known as Cadila Healthcare, was one of the first abbreviated new drug approval (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 25mg and 50mg tablets.
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 Zydus group’s formulation manufacturing facility at Ahmedabad SEZ, India.
Mirabegron extended-release tablets USP 25mg and 50mg had annual sales of $2.42 billion I n the USA, according to IQVIA data (IQVIA MAT August 2022).
The Zydus group now has 324 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04.