Justify bioequivalent data: CDSCO Panel Tells Sun Pharma on Mirabegron Extended-release Tablets
New Delhi: After reviewing the bioequivalence (BE) report of Mirabegron extended-release Tablets 50 mg presented by drug major Sun Pharma, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to justify the product is bioequivalent with the reference product.
This came after the drug major Sun Pharma proposed manufacturing and marketing permission for Mirabegron extended release Tablets 25 mg and 50 mg and presented the BE report of Mirabegron extended-release Tablets 50mg for which permission has been taken from the BA/BE Export Division before the committee.
Mirabegron is a beta-3 adrenergic agonist used to treat overactive bladder and neurogenic detrusor overactivity. Mirabegron has been shown to have a high safety and efficacy profile by large random placebo-controlled clinical trials. Mirabegron is used to treat urgency, urge urinary incontinence, and increased urinary frequency found in the overactive bladder.
Mirabegron is a medication used in the management of overactive bladder. It is in the sympathomimetic class of medications. It received approval from the US Food and Drug Administration (FDA) in June 2012 for treating overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
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