Sun Pharma gets CDSCO nod to manufacture, market FDC Silodosin JP plus Tadalafil

New Delhi: Based on the Phase III Clinical trial (CT) of the Fixed Dose Combination (FDC) Silodosin JP plus Tadalafil presented by the drug major Sun Pharma, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted the permission to manufacture and market the fixed dose combination Silodosin JP plus Tadalafil.

This came after the firm presented their proposal along with Phase III CT report before the committee.

The firm informed that BE report has already been presented on 26.08.2021 and the same was considered by the committee.

Silodosin is an antagonist of α 1 -adrenoceptors, with the highest selectivity for the α 1A -adrenoceptor subtype. By blocking the α 1A -adrenoceptor signalling pathway, silodosin promotes prostatic and urethral smooth muscle relaxation, thereby improving lower urinary tract symptoms.

Silodosin is an alpha-blocker that is used to improve urination in men with benign prostatic hyperplasia ( enlarged prostate ). Silodosin may also be used for purposes not listed in this medication guide. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tadalafil is a phosphodiesterase 5 inhibitor used to treat erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension.

Tadalafil is indicated for the treatment of erectile dysfunction (ED) and either alone or in combination with finasteride for the treatment of benign prostatic hypertrophy (BPH). It is also indicated for the treatment of pulmonary arterial hypertension (PAH) both alone and in combination with macitentan or other endothelin-1 antagonists.

Inhibition of PDE5 by tadalafil increases signaling via the PKG cascade which supports penile smooth muscle relaxation during sexual arousal by decreasing Ca2+ entry into smooth muscle cells. This smooth muscle relaxation allows blood to fill the corpus cavernosum thereby producing an erection.

At the recent SEC meeting for Reproductive & Urology held on 19th October 2023, the expert panel reviewed the proposal along with Phase III CT report of the FDC Silodosin JP plus Tadalafil.

After detailed deliberation, the committee recommended for grant of permission to manufacture and market the proposed FDC.

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