CDSCO Panel Rejects MSN Laboratories Proposal For Combikit of Silodosin Capsules plus Mirabegron
New Delhi: Highlighting that there is no unmet need for the proposed Combi kit of Silodosin Capsules 8mg/8mg plus Mirabegron extended released (ER) Tablets 25mg/50mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has rejected the proposal presented by the drug major MSN Laboratories for the Phase III clinical trial and bioequivalence (BE) study waiver of the proposed Combkit.
This came after MSN Laboratories presented its proposal along with a request for a Phase III clinical trial and BE study waiver before the committee.
Silodosin is used to treat signs and symptoms of an enlarged prostate gland, which is also known as benign enlargement of the prostate (benign prostatic hyperplasia or BPH). Benign enlargement of the prostate is a problem that can occur in men as they get older. The prostate gland is located below the 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.
Combipack of Mirabegron Extended-Release 25 mg and Silodosin 8 mg is a combination medication used for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in men. Mirabegron is an oral medication that belongs to the class of beta-3 adrenergic receptor agonists.
At the recent SEC meeting for Reproductive and Urology held on 20 September 2023, the expert panel reviewed the proposal presented by the drug major MSN Laboratories for the Phase III clinical trial and BE study waiver of the Combikit of Silodosin Capsules 8mg/8mg plus Mirabegron ER Tablets.
After detailed deliberation, the committee noted that:-
1) The firm has not presented any scientific justification and needs for the proposed Combi kit.
2) The single drug of the proposed strength is already approved and FDC of Silodosin 8mg/8mg + Mirabegron ER 25mg/50mg tablet is also recommended for CT study, the firm did not present any benefit over the FDC and approved single drugs.
3) There is no unmet need.
Accordingly, the committee didn’t recommend approval of the proposed Combi kit.
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