Zydus Lifesciences gets final FDA approval for Mirabegron generic

Zydus Lifesciences (previously Cadila Healthcare) said that its US subsidiary Zydus Pharmaceuticals (USA) has secured final approval from the US Food and Drug Administration (FDA) for marketing Mirabegron Extended-Release Tablets USP 25 mg and 50 mg.

The product is a generic of Myrbetriq, which has approval for the treatment of overactive bladder (OAB) with symptoms that include urge urinary incontinence, urgency, and urinary frequency.

Zydus Lifesciences said that it was among the first abbreviated new drug application (ANDA) applicants for filing a substantially complete ANDA with a paragraph IV certification for the Myrbetriq generic in 25 mg and 50 mg strengths. Due to this, Zydus Pharmaceuticals (USA) is eligible for 180 days of shared generic drug exclusivity for Mirabegron Extended Release Tablets, 25 mg and 50 mg.

Zydus Lifesciences gets final FDA approval for Mirabegron generic. Photo courtesy of Zydus Cadila.

The Indian pharma company will manufacture the urinary drug at its formulation manufacturing facility in Ahmedabad SEZ.

According to IQVIA data (IQVIA MAT August 2022), Mirabegron Extended-Release Tablets USP 25mg and 50mg had annual US sales of $2.42 billion.

Recently, Zydus Lifesciences won final FDA approval for pulmonary hypertension drug — Sildenafil for Oral Suspension USP 10 mg/ml.