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.
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