Akums gets CDSCO panel nod to manufacture, market FDC Alfuzosin HCL,Tadalafil film coated tablets
New Delhi: Drug major Akum Pharmaceuticals has received a green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the fixed-dose combination (FDC) Alfuzosin Hydrochloride IP (as Extended Release) 10 mg/10 mg plus Tadalafil IP 2.5 mg/5 mg film-coated tablets.
However, this recommendation is subject to the condition that the firm conduct the active post-marketing surveillance (PMS) study for secondary efficacy and tolerability, including erectile dysfunction (ED) parameters.
This came after the firm presented the Phase III clinical trial study report of the FDC Alfuzosin Hydrochloride IP (as Extended Release) 10 mg/10 mg plus Tadalafil IP 2.5 mg/5 mg film-coated tablets before the committee.
Alfuzosin is an alpha-1 adrenergic antagonist used in the symptomatic management of benign prostatic hypertrophy (BPH). Alfuzosin selectively binds to and inhibits alpha(1)-adrenergic receptors in the lower urinary tract. This leads to the relaxation of smooth muscle in both the prostate and bladder neck, resulting in an improvement in urine flow and a reduction of urinary symptoms.
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