Ajanta Pharma Gets CDSCO Panel Nod To Manufacture, Market Tadalafil Oral Jelly for Erectile Dysfunction
New Delhi: Granting the clinical trial study waiver, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has given its nod to Ajanta Pharma to manufacture and market Tadalafil Oral jelly 20mg (Orange flavor) for the treatment of erectile dysfunction in adult men.
This came after the firm presented the proposal for manufacturing and marketing of Tadalafil oral jelly 20mg. The firm presented the results of the Bioequivalence study report along with the justification for the clinical trial waiver.
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 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 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 Ajanta Pharma for the manufacturing and marketing of Tadalafil oral jelly 20mg.
The committee noted that the Tadalafil oral jelly 20mg is found bioequivalent with the reference product i.e. Tadalafil tablets 20 mg.
After detailed deliberation, the committee considered the request of the firm for waiver of clinical trial and recommended the grant of manufacturing permission for Tadalafil oral jelly 20mg for the indication “for the treatment of erectile dysfunction in adult men.
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