Zydus Lifesciences US arm bags USFDA nod for generic version of Mirabegron ER tablets

Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and urinary frequency.

Published On 2022-10-03 06:45 GMT | Update On 2022-10-03 06:45 GMT

New Delhi: Zydus Lifesciences on Monday said it has received the final nod from the US Food and Drug Administration (USFDA) to market its generic version of Mirabegron extended-release tablets used to treat overactive bladder, with 180 days of shared generic drug exclusivity.The final approval granted by the US Food and Drug Administration (USFDA) to the company's US arm Zydus...

New Delhi: Zydus Lifesciences on Monday said it has received the final nod from the US Food and Drug Administration (USFDA) to market its generic version of Mirabegron extended-release tablets used to treat overactive bladder, with 180 days of shared generic drug exclusivity.

The final approval granted by the US Food and Drug Administration (USFDA) to the company's US arm Zydus Pharmaceuticals Inc is for the tablets of strengths 25 mg and 50 mg, it said in a regulatory filing.

Zydus was one of the first applicants to submit a substantially complete ANDA (abbreviated new drugs application) with a paragraph IV certification for Mirabegron extended-release tablets, 25 mg, and 50 mg, and is, therefore, eligible for 180 days of shared generic drug exclusivity for the drug, it added.

Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and urinary frequency.

The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, the filing added.

As per IQVIA MAT August 2022 data, Zydus said Mirabegron extended-release tablets 25mg and 50mg had annual US sales of USD 2.42 billion.

Zydus group is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil. Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and in the high-profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.

Article Source : with inputs

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Zydus Lifesciences US arm bags USFDA nod for generic version of Mirabegron ER tablets

Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and urinary frequency.

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