Akums Pharma Gets CDSCO Panel Nod To Manufacture, Market Tamsulosin HCL, Tadalafil FDC Tablet
New Delhi: The drug major Akums Drugs and Pharmaceuticals has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the fixed-dose combination of the drug Tamsulosin HCL I.P 0.4mg (As Extended Release Form) plus Tadalafil I.P. 2.5mg (Film Coated) Tablet.
This permission is conditional on the firm conducting Phase IV clinical trials with a larger sample size (about 300) and study centers spread out geographically across the country.
This came after the drug major Akums Drugs and Pharmaceuticals presented its proposal before the committee along with a bioequivalence (BE) study report for higher strength and Phase IV clinical trial protocol.
For the treatment of erectile dysfunction, a medication combination of tamsulosin and tadalafil is used. Tamsulosin helps to facilitate easy urine flow by relaxing the muscles in the prostate and bladder. Tadalafil prevents the function of an enzyme called phosphodiesterase, which relaxes the blood vessels in the penis and leads to an increase in blood flow, which causes an erection.
Tamsulosin is in a class of medications called alpha-blockers. It works by relaxing the muscles in the prostate and bladder so that urine can flow easily. Tamsulosin is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia or BPH) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, urinary frequency, and urgency.
Tadalafil is in a class of medications called phosphodiesterase (PDE) inhibitors. It treats erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Tadalafil (Cialis) is used to treat erectile dysfunction (ED, impotence; inability to get or keep an erection), and the symptoms of benign prostatic hyperplasia (BPH; an enlarged prostate) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency in adult men.
Tadalafil (Adcirca) is used to improve the ability to exercise in people with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness).
At the recent SEC meeting for Reproductive and Urology held on 21st June 2023, the expert panel reviewed the proposal presented by Akums Drugs and Pharmaceuticals along with the bioequivalence (BE) study report of the FDC Tamsulosin HCL plus Tadalafil tablet for higher strength and Phase IV clinical trial protocol.
After detailed deliberation, the committee recommended the grant of manufacturing and marketing permission for the said FDC subject to the condition that the firm should conduct a Phase IV clinical trial with an increased sample size (approx. 300) and study centers geographically distributed in the country.
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